"医疗器械生产许可信息通告(2019年第25期)

"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》延续","四川锦江电子科技有限公司","915101077348059327","李楚文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150016号","同意延续.
","43658","43658","45484","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:氨测定试剂盒(谷氨酸脱氢酶法)川械注准20192400077;乳酸测定试剂盒(乳酸氧化酶法)川械注准20192400078;减少生产产品:"尿酸测试剂盒(URO-定PAP法)川食药监械(准)字2013第2400127号;丙氨酸氨基转移酶测定试剂盒(改良赖氏法)川食药监械(准)字2014第2400018号;"血吸虫循环抗原测定试剂盒(ELISA法)国食药监械(准)字2013第3401519号;生产产品名称变更:α-L-岩藻糖苷酶质控物变更为α-L-岩藻糖苷酶质控品;α-L-岩藻糖苷酶测定试剂盒(MG-CNPF法)变更为α-L-岩藻糖苷酶测定试剂盒(CNPF底物法)","43658","43658","44067","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川普瑞斯生物科技有限公司","91511503563252148F","雷冰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170033号","产品延续注册后产品证号变更:一次性使用配药用注射器注册证号由川食药监械(准)字2014第2660076号变更为川械注准20192140097;一次性使用止液型精密过滤输液器带针注册证号由国食药监械(准)字2014第3661284号变更为国械注准20193141649、一次性使用止液型精密过滤输液器带针产品名称变更为一次性使用精密过滤输液器带针;一次性使用止液精密型袋式输液器带针注册证号由国食药监械(准)字2014第3661283号变更为国械注准20193141644;一次性使用止液型袋式输液器带针注册证号由国食药监械(准)字2014第3661282号变更为国械注准20193141711;减少生产产品:医用消毒超声耦合剂川食药监械(准)字2014第2230118号;企业负责人变更:鲍支亮变更为李竞;减少生产范围(2002年分类)Ⅱ类:6815--注射穿刺器械,6823-1-超声诊断设备;增加生产范围(2017年分类)Ⅱ类:14-02-血管内输液器械Ⅲ类:14-02-血管内输液器械;","43658","43658","45484","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克医疗电子有限公司","91510100590236741G","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170038号","增加生产产品:全自动生化分析仪川械注准20192220090.
","43658","43658","44874","四川省药品监督管理局""5","《医疗器械生产许可证》核发","四川侨源气体股份有限公司","91510100740341476L","乔志涌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190031号","新核发.
法定代表人为乔志涌;企业负责人为李国平;住所为四川省成都市都江堰市灌温路1399号;生产地址为四川省成都市都江堰市灌温路1399号4号车间.
","43658","43658","45484","四川省药品监督管理局""6","《医疗器械生产许可证》企业负责人变更","成都昌华科技有限责任公司","91510100792152378M","陈昌标","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150010号","企业负责人由熊琼变更为陈昌元.
","43661","43661","45454","四川省药品监督管理局""7","《医疗器械生产许可证》生产地址文字性变更","成都市新兴内窥镜科技有限公司","915101082022156674","王传林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150043号","生产地址文字性变更由成都市新都县新都镇团结村一社变更为成都市新都区新都街道自强路66号.
","43661","43661","43968","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","四川千里倍益康医疗科技股份有限公司","91510108629517429X","张文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150040号","减少生产产品:空气波压力治疗仪(肢体加压理疗设备)川食药监械(准)字2014第2260081号(更);增加生产产品:空气波压力治疗仪川械注准20192090101;减少生产范围(2002年分类)6826-5-理疗康复仪器;增加生产范围生产范围(2017年分类)09-04-力疗设备/器具","43662","43662","43949","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","成都华信高科医疗器械有限责任公司","91510124713035326C","陈兵","普通","《医疗器械生产许可证》(含生产产品登记表)","2019041838778000001","住所由郫都区成都现代工业港南片区清马路369号变更为成都市郫都区成都现代工业港南片区清马路369号;生产地址文字性变更由郫都区成都现代工业港南片区清马路369号变更为成都市郫都区成都现代工业港南片区清马路369号;减少生产范围(2002年分类)6854-7-呼吸设备配件;减少生产产品:一次性使用麻醉可视喉镜(气管插管联合套件)川械注准20142540014.
","43662","43662","45390","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","减少生产范围(2017年分类)Ⅱ类:14-03-非血管内输液器械Ⅲ类:14-02-血管内输液器械,22-11-采样设备和器具;增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;产品延续注册后注册证号变更:医用口罩帽子注册证号川食药监械(准)字2014第2640085号变更为川械注准20192140099;一次性使用无菌产包注册证号川食药监械(准)字2014第2640086号变更为川械注准20192140100;一次性使用无菌手术包注册证号川食药监械(准)字2014第2640084号变更为川械注准20192140098.
","43662","43662","43949","四川省药品监督管理局""11","《医疗器械生产许可证》增加生产范围/增加生产产品","四川阿尔泰医疗器械有限公司","91510681665385216T","黄永兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160025号","增加生产产品:金属锁定接骨板国械注准20193130372.
","43664","43664","44307","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","奥泰医疗系统有限责任公司","91510100771215088D","雷旸","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160024号","增加生产范围(2017年分类)Ⅱ类:06-01-诊断X射线机,06-07-超声影像诊断设备Ⅲ类:06-09-磁共振成像设备(MRI);增加生产产品磁共振成像系统国械注准20193060427.
","43671","43671","44304","四川省药品监督管理局""13","《医疗器械生产许可证》延续","成都肯格王三氧电器设备有限公司","91510105709271609E","尖锋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150028号","同意延续.
","43671","43671","45497","四川省药品监督管理局""14","《医疗器械生产许可证》延续","遂宁市维美义齿制作有限公司","91510900551002539T","阳彪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149011号","同意延续.
","43671","43671","45497","四川省药品监督管理局""15","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","减少生产产品:甲型流感病毒抗原检测试剂盒(胶体金法)国食药监械(准)字2014第3401534号;增加生产产品:1糖类抗原19-9测定试剂盒(直接化学发光法)国械注准20193400383;2甲胎蛋白测定试剂盒(直接化学发光法)国械注准20193400384;3游离前列腺特异性抗原测定试剂盒(直接化学发光法)国械注准20193400385;4癌胚抗原测定试剂盒(直接化学发光法)国械注准20193400386;5糖类抗原125测定试剂盒(直接化学发光法)国械注准20193400387;6糖类抗原15-3测定试剂盒(直接化学发光法)国械注准20193400417;7总前列腺特异性抗原测定试剂盒(直接化学发光法)国械注准20193400419;8全段甲状旁腺激素测定试剂盒(化学发光法)川械注准20192400107;9全段甲状旁腺激素质控品川械注准20192400108;10全段甲状旁腺激素校准品(化学发光法)川械注准20192400109;11甲型流感病毒抗原检测试剂盒(胶体金法)国械注准20193401923.
","43671","43671","44067","四川省药品监督管理局""16","《医疗器械生产许可证》核发","四川省至圣贝尔医疗器械有限公司","91510700MA62T2BR47","衡孝伟","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190035号","新核发.
法定代表人为衡孝伟;企业负责人为衡孝伟;住所为绵阳高新区路南工业区6幢;生产地址为绵阳高新区路南工业区6幢;生产范围为2002分类目录Ⅱ类:6854-8-医用制气设备2017分类目录Ⅱ类:08-04-医用制氧设备.
","43671","43671","45497","四川省药品监督管理局""17","《医疗器械生产许可证》核发","成都德信安创新医疗技术有限公司","91510115MA61WU232H","武迪蒙","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190033号","新核发.
法定代表人为武迪蒙;企业负责人为武迪蒙;住所为成都市温江区八一路北段18号1栋6单元;生产地址为成都市温江区八一路北段18号1栋6单元;生产范围为2002分类目录Ⅱ类:6809-3-泌尿肛肠科用钳,6866-4-导管、引流管2017分类目录Ⅱ类:02-12-手术器械-穿刺导引器,14-05-非血管内导(插)管.
","43671","43671","45497","四川省药品监督管理局""18","《医疗器械生产许可证》核发","成都视见医疗科技有限公司","91510100MA6C87C751","陈浩","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190032号","新核发.
法定代表人为陈浩;企业负责人为陈浩;住所为中国(四川)自由贸易试验区成都高新区益州大道1999号4号楼20层;生产地址为中国(四川)自由贸易试验区成都高新区益州大道1999号4号楼20层2008室.
","43671","43671","45497","四川省药品监督管理局""19","《医疗器械生产许可证》核发","四川惟思美医疗科技有限公司","91512000MA66U4X59D","陈悟","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190034号","新核发.
法定代表人为陈悟;企业负责人为陆贵山;住所为四川省资阳市现代大道3号B栋三层C区;生产地址为四川省资阳市现代大道3号B栋三层C区;生产范围为2002分类目录Ⅱ类:6855-1-口腔综合治疗设备2017分类目录Ⅱ类:17-03-口腔治疗设备.
","43671","43671","45497","四川省药品监督管理局""20","《医疗器械生产许可证》核发","四川贝利福医疗器械有限公司","91512000MA67QL9B05","颜伟洁","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190036号","新核发.
法定代表人为颜伟洁;企业负责人为杨兴伦;住所为四川省资阳市现代大道3号C栋三层A、B1、B2、C1区;生产地址为四川省资阳市现代大道3号C栋三层A、B1、B2、C1区;生产范围为2002分类目录Ⅱ类:6855-1-口腔综合治疗设备2017分类目录Ⅱ类:17-03-口腔治疗设备.
","43671","43671","45497","四川省药品监督管理局""21","《医疗器械生产许可证》增加生产范围/增加生产产品","成都领翔义齿技术有限公司","915101155589977782","杜斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150002号","定制式固定义齿的注册号由川食药监械注(准)字2011第2630057号变更为川械注准20152630079;定制式活动义齿的注册号由川食药监械注(准)字2011第2630056号变更为川械注准20152630080.
","43675","43675","43837","四川省药品监督管理局""22","《医疗器械生产许可证》增加生产范围/增加生产产品","成都康富科学仪器有限公司","91510107556442912X","杨定文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150029号","超声电导治疗仪的注册证号由"川食药监械(准)字2013第2230008号"变更为"川械注准20172230181".
","43676","43676","43920","四川省药品监督管理局""23","《医疗器械生产许可证》生产地址文字性变更","成都威力生生物科技有限公司","91510100794916300L","陈贵文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160053号","住所由成都市高新区科园南路88号天府生命科技园B6幢301变更为成都市高新区科园南路88号天府生命科技园B6幢301;生产地址文字性变更由成都市高新区科园南路88号天府生命科技园B6幢302变更为高新区科园南路88号10栋3楼303、304号.
","43676","43676","44477","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第26期)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》延续","成都华神生物技术有限责任公司","915101007801171102","张文武","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150013号","同意延续.
","43677","43677","45503","四川省药品监督管理局""2","《医疗器械生产许可证》延续","绵阳立德电子股份有限公司","91510700717509138R","文云洋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150003号","同意延续.
","43677","43677","45503","四川省药品监督管理局""3","《医疗器械生产许可证》核发","成都邦研科技有限公司","91510124098669350G","刘光友","普通","《医疗器械生产许可证》(含生产产品登记表)","2019071017766000001","不同意申请人持有的《医疗器械生产许可证》核发.
","43677","43677","/","四川省药品监督管理局""4","《医疗器械生产许可证》核发","四川精益永创科技有限公司","91510100350604955Y","孙玉凡","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190039号","新核发.
法定代表人为孙玉凡;企业负责人为孙玉凡;住所为成都市高新区益州大道1999号15栋7楼705号;生产地址为成都市高新区益州大道1999号15栋7楼705号;生产范围为2002分类目录Ⅱ类:6870-4-影象档案传输、处理系统软件2017分类目录Ⅱ类:21-02-影像处理软件.
","43677","43677","45503","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川国纳科技有限公司","91510100730214035G","曹侠","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160062号","增加生产范围(2017年分类)Ⅱ类:02-12-手术器械-穿刺导引器;增加生产产品:一次性使用穿刺器川械注准20192020119.
","43677","43677","44548","四川省药品监督管理局""6","《医疗器械生产许可证》核发","四川山岳生物科技有限公司","91512000MA666JH9XX","周文波","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190037号","新核发.
法定代表人为周文波;企业负责人为周文波;住所为四川省资阳市现代大道3号A栋四层D、E、F区;生产地址为四川省资阳市现代大道3号A栋四层D、E、F区;生产范围2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-09-不可吸收外科敷料.
","43677","43677","45503","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省崇州锦海医疗器械有限公司","91510184582600064U","胡燕","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170026号","减少生产范围(2002年分类)6858-2-医用低温设备;增加生产范围(2017年分类)Ⅱ类:09-02-温热(冷)治疗设备/器具;全自动冷疗仪的注册证号由川食药监械(准)字2014第2580069号变更为川械注准20192090096.
","43677","43677","44795","四川省药品监督管理局""8","《医疗器械生产许可证》核发","四川明峰医疗科技有限公司","91510131MA6C8YK61E","潘华素","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190038号","新核发.
法定代表人为潘华素;企业负责人为许泽卫;住所为成都市蒲江县寿安镇青蒲路863号;生产地址为成都市蒲江县寿安镇青蒲路863号;生产范围为2002分类目录Ⅲ类:6830-3-X射线计算机体层摄影设备(CT)2017分类目录Ⅲ类:06-02-X射线计算机体层摄影设备(CT).
","43677","43677","45503","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","成都利尼科医学技术发展有限公司","91510115669664933Q","王健","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149013号","医用电子直线加速器的注册证号由国食药监械(准)字2013第3321485号变更为国械注准20173324489.
","43682","43682","43827","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第27期)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》延续","成都欧赛医疗器械有限公司","91510122768647821B","甘释良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150011号","同意延续.
","43690","43690","45516","四川省药品监督管理局""2","《医疗器械生产许可证》生产地址非文字性变更","攀枝花市川美义齿制作有限公司","915104020644598655","樊正萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150053号","生产地址非文字性变更由四川省攀枝花市东区银江镇华山村老熊箐社(巴斯箐处)171栋2楼变更为攀枝花市仁和区仁和镇仁和新村商业街西6号楼(正商街48号)3楼301.
","43690","43690","44020","四川省药品监督管理局""3","《医疗器械生产许可证》生产地址非文字性变更","卡瓦(四川)医疗器械有限公司","91512000MA66NA1L43","侯刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190002号","生产地址非文字性变更由四川省资阳市现代大道3号A栋一层E2、F区变更为四川省资阳市现代大道3号A栋一层E2、F区,二层楼A、B、C区.
","43690","43690","45298","四川省药品监督管理局""4","《医疗器械生产许可证》延续","成都四维齿科技术开发有限公司","915101006771749772","陈伟","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150044号","同意延续.
","43690","43690","45516","四川省药品监督管理局""5","《医疗器械生产许可证》延续","成都太合生物材料有限公司","9151013172036104XA","吴锐","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150017号","同意延续.
","43690","43690","45516","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","成都维信电子科大新技术有限公司","9151010062171126X9","陈志强","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149002号","增加生产范围(2017年分类)08-05-呼吸、麻醉、急救设备辅助装置;增加生产产品:压缩式雾化器川械注准20192080087.
","43690","43690","45442","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150057号","减少生产范围(2002年分类)6845-4-血液净化设备和血液净化器具;增加生产范围(2017年分类)Ⅲ类:10-02-血液分离、处理、贮存器具;产品延续注册后变更注册证号:1一次性使用去白细胞输血器的注册证号由国械注准20143662286变更为国械注准20143102286;2一次性使用机采血细胞分离器的注册证号由国械注准20143452278变更为国械注准20143102278;3一次性使用静脉输液针的注册证号由国械注准20143152280变更为国械注准20143142280;4一次性使用血小板用去白细胞输血器的注册证号由国械注准20143662276变更为国械注准20143102276.
","43692","43692","44045","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","华西医科大学卫生部口腔种植科技中心","91510100201994822T","王安文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150023号","牙种植体的注册证号由国食药监械(准)字2014第3630936号变更为国械注准20193171832.
","43692","43692","43906","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第28期)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》核发","四川九阵科技股份有限公司","91511000MA62704X37","罗丹","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190040号","新核发.
法定代表人为罗丹;企业负责人为罗丹;住所为四川省内江市东兴区兰桂大道377号三单元16楼1605-1号;生产地址为四川省内江市东兴区兰桂大道377号三单元16楼1605-1号;生产范围为2002分类目录Ⅱ类:6870-2-诊断图象处理软件2017分类目录Ⅱ类:21-02-影像处理软件.
","43697","43697","45523","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","南充市瑞斯德义齿制作中心","91511302MA6CJM221W","覃凤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190041号","定制式固定义齿的注册号由川食药监械(准)字2014第2630027号变更为川械注准20182630111,定制式活动义齿的注册号由川食药监械(准)字2014第2630026号变更为川械注准20182630112.
","43699","43699","43949","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都博奥晶芯生物科技有限公司","91510115577375018L","宋云鹏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150041号","增加生产范围(2017年分类)Ⅲ类:22-05-分子生物学分析设备;增加生产产品:恒温扩增核酸分析仪国械注准20193220539.
","43699","43699","43949","四川省药品监督管理局""4","《医疗器械生产许可证》核发","成都科一生物科技有限公司","91510115072446060U","马刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190042号","新核发.
法定代表人为马刚;企业负责人为马刚;住所为成都市温江区成都海峡两岸科技产业开发园新华大道二段760号;生产地址为成都市温江区成都海峡两岸科技产业开发园新华大道二段760号8号厂房;生产范围为2002分类目录Ⅱ类:6840-3-免疫分析系统2017分类目录Ⅱ类:22-04-免疫分析设备.
","43699","43699","45525","四川省药品监督管理局""5","《医疗器械生产许可证》核发","四川上元医疗科技有限公司","91510700MA6249J4XY","王家奎","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190041号","新核发.
法定代表人为王家奎;企业负责人为吴义传;住所为绵阳科创区创新中心二期8号楼115号;生产地址为四川省绵阳市九盛路兴隆社区企业加速器B区204;生产范围为2002分类目录Ⅱ类:6826-5-理疗康复仪器2017分类目录Ⅱ类:09-08-其他物理治疗设备.
","43699","43699","45525","四川省药品监督管理局""6","《医疗器械生产许可证》核发","四川华思美义齿制作有限公司","91510921MA67PRC35W","韩中华","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190043号","新核发.
法定代表人为韩中华;企业负责人为庞思璇;住所为蓬溪县赤城镇上游工业园区;生产地址为蓬溪县赤城镇上游工业园区四川百皇门业有限公司内办公楼1楼右侧(1-4轴)、2楼201室;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿2017分类目录Ⅱ类:17-06-口腔义齿制作材料.
","43700","43700","45526","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","绵阳美科电子设备有限责任公司","91510700MA6242UH7Q","赵文军","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150018号","减少生产产品:数字化B型超声诊断仪,注册证号为川食药监械(准)字2014第2230041号.
","43706","43706","43898","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","成都欧赛医疗器械有限公司","91510122768647821B","甘释良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150011号","生产地址非文字性变更由成都市双流区西南航空港经济开发区西航港大道2401号1栋,2栋1、3、4层,3栋1-A、2、3、4层,6栋2、3、4层变更为成都市双流区西南航空港经济开发区西航港大道2401号1栋,2栋1、3、4层;增加生产产品:一次性使用血液灌流器国械注准20193100567;增加生产范围(2017年分类)Ⅲ类:10-04-血液净化及腹膜透析器具.
","43706","43706","43856","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第29期)"1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川普瑞斯生物科技有限公司","91511503563252148F","雷冰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170033号","增加生产产品:1一次性使用低阻力配药用注射器川械注准20192140141;2一次性使用正压静脉留置针国械注准20193140497.
","43707","43707","45484","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:1乙型肝炎病毒表面抗原检测试剂盒(胶体金法)国械注准20193400528;2乙型肝炎病毒核酸测定试剂盒(荧光PCR法)国械注准20193400557.
","43707","43707","44067","四川省药品监督管理局""3","《医疗器械生产许可证》核发","达州市鑫宇义齿有限公司","91511702MA66T9U15J","肖洪登","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190044号","新核发.
首次注册产品定制式固定义齿(注册证号:川械注准20192170124)、定制式活动义齿(注册证号:川械注准20192170125)申报核发《医疗器械生产许可证》.
生产范围:2002分类目录Ⅱ类:6863-16-定制式义齿2017分类目录Ⅱ类:17-06-口腔义齿制作材料","43713","43707","45539","四川省药品监督管理局""4","《医疗器械生产许可证》住所变更/生产地址非文字性变更","成都市萨尼医疗器械有限公司","91510100395770519K","何春霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170020号","住所由"成都市双流区西南航空港经济开发区西航港大道2401号"变更为"中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区西航港大道中四段2401号附2号";生产地址非文字性变更:"成都市西航港大道2401号4栋1楼左侧、2楼"变更为"成都市双流区黄甲街道西航港大道2401号4栋1楼、2楼"","43713","43713","44737","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产产品(增加受托生产产品)","成都思维特医疗器械有限公司","91510104350524146A","杨桂华","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190007号","增加受托生产产品"一次性无创脑电传感器"(SY-S001、SY-S002),粤械注准20182210520","43713","43713","45312","四川省药品监督管理局""6","《医疗器械生产许可证》生产地址非文字性变更","四川沃文特生物技术有限公司","91510100577371682N","杨龙贤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150063号","生产地址非文字性变更:"成都市高新区(西区)西芯大道6号3栋1层1号101室、102室、2层1号"变更为"成都市高新区(西区)西芯大道6号3栋1层1号101室、102室、2层1号、2层2号、3层303号"","43713","43713","44055","四川省药品监督管理局""7","《医疗器械生产许可证》延续","成都市万福实业工程有限公司","915101247092429206","高原","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150015号","同意延续.
","43713","43713","45539","四川省药品监督管理局""8","《医疗器械生产许可证》延续","成都康富科学仪器有限公司","91510107556442912X","杨定文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150025号","同意延续.
","43713","43713","45539","四川省药品监督管理局""9","《医疗器械生产许可证》延续","成都青山利康药业有限公司","91510100732384126D","刘革新","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150004号","同意延续.
","43713","43713","45539","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产产品","卡瓦(四川)医疗器械有限公司","91512000MA66NA1L43","侯刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190002号","增加生产产品:口腔颌面锥形束计算机体层摄影设备(注册证号:国械注准20193060526)","43713","43713","45298","四川省药品监督管理局""11","《医疗器械生产许可证》核发","四川深图医学影像设备有限公司","91510521MA694ME15N","王益民","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190045号","首次注册产品数字化X射线系统(注册证号:川械注准20192060131)、数字化X射线系统(注册证号:川械注准20192060132)申请核发《医疗器械生产许可证》","43713","43713","45539","四川省药品监督管理局""12","《医疗器械生产许可证》核发","四川霖优生物科技有限公司","91510100321603005F","郭宝刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190046号","首次注册产品C反应蛋白测定试剂盒(胶乳增强免疫比浊法)(注册证号:川械注准20192400046)、超敏C反应蛋白测定试剂盒(胶乳增强免疫比浊法)(注册证号:川械注准20192400047)、血清淀粉样测定试剂盒(胶乳增强免疫比浊法)(注册证号:川械注准20182400048)、IV型胶原蛋白测定试剂盒(胶乳增强免疫比浊法)(注册证号:川械注准20182400049)、降钙素原测定试剂盒(胶乳增强免疫比浊法)(注册证号:川械注准20182400052)申报核发《医疗器械生产许可证》","43713","43713","45539","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第30期)"1","《医疗器械生产许可证》变更住所生产地址","成都美益达医疗科技有限公司","915101000600892000","张晓金","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150045号","1.
《医疗器械生产许可证》登记事项变更生产地址由"成都高新区西部园区合瑞南路9号(主楼)四楼"变更为"成都高新区天映路102号(主楼)四楼".
2.
住所变更由"成都高新区西部园区合瑞南路9号"变更为"成都高新区天映路102号".
","43727","43727","43968","四川省药品监督管理局""2","《医疗器械生产许可证》延续","华西医科大学卫生部口腔种植科技中心","91510100201994822T","王安文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150023号","同意延续.
","43734","43734","45560","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都昌华科技有限责任公司","91510100792152378M","陈昌标","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150010号","减少生产产品:1、一次性无菌加强型气管插管(注册证号:川食药监械(准)字2014第2660131号;2、一次性无菌双腔支气管插管(川食药监械(准)字2014第2660132号.
增加生产产品:1、一次性无菌双腔支气管插管(注册证号:川械注准20192080150);2、一次性无菌加强型气管插管(川械注准20192080151)","43734","43734","45454","四川省药品监督管理局""4","《医疗器械生产许可证》生产地址非文字性变更","四川霖优生物科技有限公司","91510100321603005F","郭宝刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190046号","增加生产产品:特定蛋白分析仪(注册证号:川械注准20182220169);生产地址由"四川省成都市高新区(西区)西芯大道17号1号楼一楼1102区域"变更为"四川省成都市高新区(西区)西芯大道17号1号楼一楼1102区域、四川省成都市高新区(西区)西芯大道17号2号楼一楼2103区域".
","43734","43734","45539","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产产品","四川沃文特生物技术有限公司","91510100577371682N","杨龙贤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150063号","增加生产产品:自动粪便处理分析系统(注册证号:川械注准201922220140)","43734","43734","44055","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产产品","四川新健康成生物股份有限公司","9151010079780219XP","王大平","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170002号","增加生产产品:1、全自动生化分析仪(注册证号:川械注准20192220021);2、肌钙蛋白测定试剂盒(免疫荧光层分析法)(注册证号:川械注准20192400139);3、α-L-岩藻糖苷酶测定试剂盒(CNPF底物法)(注册证号:国械注准20193400466);4、白介素6测定试剂盒(免疫荧光层析法)(注册证号:川械注准20192400135);5、N末端心房利钠肽测定试剂盒(免疫荧光层析法)(注册证号:川械注准20192400138);6、血清淀粉样蛋白A测定试剂盒(免疫荧光层析法)(注册证号:川械注准20192400134);7、肌红蛋白/肌酸激酶同工酶/肌钙蛋白I三联卡测定试剂盒(免疫荧光层析法)(注册证号:川械注准20192400137);8、血清淀粉样蛋白A测定试剂盒(胶乳免疫比浊法)(注册证号:川械注准20192400136).
","43734","43734","44583","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:1、超敏C-反应蛋白测定试剂盒(荧光免疫层析法)(注册证号:川械注准20192400152);2、尿微量白蛋白测定试剂盒(荧光免疫层析法)(注册证号:川械注准20192400153);3、N末端脑利钠肽前体测定试剂盒(荧光免疫层析法)(注册证号:川械注准20192400154).
","43734","43734","44067","四川省药品监督管理局""8","《医疗器械生产许可证》核发","成都市博雅义齿技术有限公司","91510115091262718J","黄旭","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190049号","新核发.
法定代表人为黄旭;企业负责人为段珍明;住所为成都温江区蓉台大道北段288号"海峡中小企业孵化园"园区内(7幢2层1-4轴);生产地址为成都温江区蓉台大道北段288号"海峡中小企业孵化园"园区内(7幢2层1-4轴).
","43734","43734","45560","四川省药品监督管理局""9","《医疗器械生产许可证》核发","资阳迪耀科技有限公司","91512000MA63P8H4XC","李允基","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190048号","新核发.
首次注册产品定制式固定义齿(注册证号:川械注准20192170167).
","43734","43734","45560","四川省药品监督管理局""10","《医疗器械生产许可证》减少/增加生产产品","中国核动力研究设计院设备制造厂","915111269075114823","罗绮","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150066号","减少生产产品:1、放射治疗模拟机(注册证号:国食药监械(准)字2014第3321316号);2、钴-60后装治疗机(注册证号:国食药监械(准)字2014第3331658号);3、放射治疗模拟机(注册证号:国食药监械(准)字2014第3321635号).
增加生产产品:1、放射治疗模拟机(注册证号:国械注准20193051861);2、放射治疗模拟机(注册证号:国械注准20193051862);3、钴-60后装治疗机(注册证号:国械注准20193051858)","43734","43734","44082","四川省药品监督管理局""11","《医疗器械生产许可证》核发","四川绵竹鸿基制药有限责任公司","91510683738346526R","廖达成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190047号","核发(旧证换新证).
原生产许可证号:川食药监械生产许(2014)第0034号,有效期至:2019年8月20日.
法定代表人为廖达成;企业负责人为廖达成;住所为四川省绵竹市江苏工业园区成青路东;生产地址为四川省绵竹市江苏工业园区成青路东.
","43734","43734","45560","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第31期)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》法定代表人变更、企业负责人变更","成都创宜生物科技有限公司","915101005510619933","向阳","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150034号","法定代表人由"陈俊"变更为"向阳";企业负责人由"杨勇军"变更为"范晞".
","43750","43750","45576","四川省药品监督管理局""2","《医疗器械生产许可证》减少/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","减少生产产品:1、一次性使用无菌导尿包(川械注准20142660019);2、一次性使用无菌备皮包(川械注准20142640029);3、一次性使用无菌换药包(川械注准20142640030).
增加生产产品:1、一次性使用无菌导尿包(川械注准20142140019);2、一次性使用无菌备皮包(川械注准20142020029);3、一次性使用无菌换药包(川械注准20142140030).
","43737","43737","43949","四川省药品监督管理局""3","《医疗器械生产许可证》核发","成都心吉康科技有限公司","91510100MA61UFJ124","李楚森","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190053号","新核发.
法定代表人为李楚森;企业负责人为李楚森;住所为中国(四川)自由贸易试验区成都高新区天府大道中段萃华路89号1栋1单元7层703号;生产地址为中国(四川)自由贸易试验区成都高新区天府大道中段萃华路89号1栋1单元7层703号;生产范围为2002分类目录Ⅱ类:6821-4-心电诊断仪器2017分类目录Ⅱ类:07-03-生理参数分析测量设备.
产品信息:1、心电手表(川械注准20192070164);2、心电记录仪(川械注准20192070163).
","43749","43749","45575","四川省药品监督管理局""4","《医疗器械生产许可证》核发","成都邦研科技有限公司","91510124098669350G","刘光友","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190050号","旧证换新证.
法定代表人由"张淼"变更为"刘光友";生产地址由"郫县成都现代工业港南片区西源大道4688号附2号1栋1层1号"变更为"成都市郫都区红光镇成都现代工业港北片区小微企业创新园长生桥路1111号24栋";住所由"郫县成都现代工业港南片区西源大道4688号附2号1栋1层1号"变更为"成都市郫都区红光镇成都现代工业港北片区小微企业创新园长生桥路1111号".
","43737","43737","45563","四川省药品监督管理局""5","《医疗器械生产许可证》延续","声泰特(成都)科技有限公司","915101007712378908","RavinderSinghSethi","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150027号","同意延续.
法定代表人为RavinderSinghSethi;企业负责人为LiuDongChyuan;住所为四川省成都高新区高朋大道5号;生产地址为四川省成都市高新区高新大道创业路16号火炬大厦A3-5/6/7;生产范围为2002分类目录Ⅱ类:6823-1-超声诊断设备.
","43749","43749","45575","四川省药品监督管理局""6","《医疗器械生产许可证》核发","四川华睿致远软件有限公司","91510105MA6CRGRNXH","徐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190052号","新核发.
法定代表人为徐勇;企业负责人为徐勇;住所为成都市青羊区光华西三路30号8栋1单元17楼1713号;生产地址为成都市青羊区光华西三路30号8栋1单元17楼1713号;生产范围为2002分类目录Ⅱ类:6870-4-影象档案传输、处理系统软件2017分类目录Ⅱ类:21-02-影像处理软件.
注册产品:医学影像存储和传输系统软件(川械注准20192210155).
","43749","43749","45575","四川省药品监督管理局""7","《医疗器械生产许可证》核发","四川华柚医疗器械有限公司","91512000MA692RTY3H","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190051号","新核发.
法定代表人为何国昆;企业负责人为李思;住所为四川省资阳市雁江区现代大道3号C栋四层G1、G2、H1、H2区;生产地址为四川省资阳市雁江区现代大道3号C栋四层G1、G2、H1、H2区;生产范围为2002分类目录Ⅲ类:6863-3-根管充填材料2017分类目录Ⅱ类:17-09-口腔治疗辅助材料.
注册产品:根管润滑剂(川械注准20192170166).
","43749","43749","45575","四川省药品监督管理局""8","《医疗器械生产许可证》延续","成都瑞琦科技实业股份有限公司","91510100713042665P","韦德","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150036号","同意延续.
法定代表人为韦德;企业负责人为韦德;住所为成都市高新区(西区)天勤东街66号;生产地址为成都市高新区(西区)天勤东街66号;生产范围为2002分类目录Ⅱ类:6840--体外诊断试剂,6841-4-血液化验设备和器具Ⅲ类:6815--注射穿刺器械2017分类目录Ⅱ类:22-11-采样设备和器具.
","43749","43749","45575","四川省药品监督管理局""9","《医疗器械生产许可证》法定代表人变更","爱齐(四川)医疗设备有限公司","91512000MA6AUMYR8R","JulieAnnColetti","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180023号","法定代表人由""RogerEdwardGeorge""变更为"JulieAnnColetti".
","43750","43750","45118","四川省药品监督管理局""10","《医疗器械生产许可证》延续","绵阳美科电子设备有限责任公司","91510700MA6242UH7Q","赵文军","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150018号","同意延续.
法定代表人为赵文军;企业负责人为赵文军;住所为绵阳高新区绵兴东路133号A214号;生产地址为绵阳市阴平路63号2#楼;生产范围为2002分类目录Ⅱ类:6823-5-便携式超声诊断设备.
","43750","43750","45576","四川省药品监督管理局""11","《医疗器械生产许可证》延续","成都美创医疗科技股份有限公司","91510100743628755X","李安民","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150031号","同意延续.
法定代表人为李安民;企业负责人为邓春雷;住所为成都市温江区成都海峡两岸科技产业开发园科林路西段618号华银工业港;生产地址为成都市温江区成都海峡两岸科技产业开发园科林路西段618号华银工业港9区11号成都市温江区天府科林路西段618号20栋1层1号201;生产范围为2002分类目录Ⅱ类:6825-1-高频手术和电凝设备,6825-5-高频电极Ⅲ类:6825-4-射频治疗设备2017分类目录Ⅱ类:16-05-眼科治疗和手术设备、辅助器具.
","43750","43750","45576","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第32期)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关","1","《医疗器械生产许可证》增加生产范围/增加生产产品","成都迪康中科生物医学材料有限公司","915101007203615413","李晓萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150048号","增加生产范围(2017年分类)Ⅱ类:14-10-创面敷料;功能性敷料(凝胶剂)的注册证号由川食药监械(准)字2014第2640143号变更为川械注准20192140146,功能性敷料(贴敷剂)的注册证号由川食药监械(准)字2014第2640144号变更为川械注准20192140147.
","43752","43752","43989","四川省药品监督管理局","2","《医疗器械生产许可证》增加生产范围/增加生产产品","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药械生产许20150057号","增加生产范围(2017年分类)14-02-血管内输液器械;一次性使用输液器带针注册证号由国械注准20143662284变更为国械注准20143142284.
","116809","43761","44045","四川省药品监督管理局","3","《医疗器械生产许可证》生产地产非文字性变更","四川博美星口腔设备有限公司","91512000MA65890F3Y","陈华志","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药械生产许20180034号","生产地址非文字性变更由四川省资阳市现代大道3号B栋2楼变更为四川省资阳市现代大道3号B栋2楼四川省资阳市现代大道3号B栋3楼B区.
","43761","43761","45197","四川省药品监督管理局","4","《医疗器械生产许可证》增加生产范围/增加生产产品","四川宇峰科技发展有限公司","91510700738312342X","吴庆扬","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药械生产许20160043号","动脉硬化检测仪注册证号由川食药监械(准)字2014第2210099号变更为川械注准20192070120;增加生产范围(2017年分类)Ⅱ类:07-03-生理参数分析测量设备;减少生产范围(2002年分类)Ⅱ类:6821-9-无创监护仪器.
","43761","43761","44391","四川省药品监督管理局","5","《医疗器械生产许可证》企业负责人变更","四川瑞珏医疗器械有限公司","91512000MA666LW58M","魏霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180040号","企业负责人由凌异变更为母春林.
","43762","43762","45222","四川省药品监督管理局","6","《医疗器械生产许可证》法定代表人变更","四川华思美义齿制作有限公司","91510921MA67PRC35W","庞思璇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190043号","法定代表人由韩中华变更为庞思璇.
","43762","43762","45526","四川省药品监督管理局","医疗器械生产许可信息通告(2019年第33期)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关","1","《医疗器械生产许可证》延续","老肯医疗科技股份有限公司","915101007130698769","刘霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149006号","同意延续.
法定代表人为刘霞;企业负责人为刘霞;住所为成都市郫县成都现代工业港北片区港通北三路211号;生产地址为成都市郫县成都现代工业港北片区港通北三路211号2栋,3栋1楼103、105;生产范围为2002分类目录Ⅱ类:6857-2-压力蒸汽灭菌设备,6857-6-专用消毒设备2017分类目录Ⅱ类:11-03-化学消毒灭菌设备,11-05-清洗消毒设备.
","43769","43769","45595","四川省药品监督管理局","2","《医疗器械生产许可证》延续","南充市瑞斯德义齿制作中心","91511302MA6CJM221W","覃凤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150038号","同意延续.
法定代表人为覃凤;企业负责人为王秋冬;住所为南充市顺庆区迎凤路3号(嘉亿纺织厂原食堂);生产地址为南充市顺庆区迎凤路3号(嘉亿纺织厂原食堂);生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿.
","43769","43769","45595","四川省药品监督管理局","3","《医疗器械生产许可证》核发","成都信通网易医疗科技发展有限公司","915101077559507681","易刚晓","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150054号","新核发.
法定代表人为易刚晓;企业负责人为易刚晓;住所为成都市武侯区武青南路33号2栋3-05-1号;生产地址为成都市武侯区武青南路33号2栋3-05-1号;生产范围为2002分类目录Ⅱ类:6870-4-影象档案传输、处理系统软件2017分类目录Ⅱ类:21-02-影像处理软件.
产品信息:1医学影像信息管理系统川械注准20192210162.
","43769","43769","45595","四川省药品监督管理局","4","《医疗器械生产许可证》核发","成都市浩瀚医疗设备有限公司","9151012274640815X0","何民瀚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150055号","新核发.
法定代表人为何民瀚;企业负责人为何民瀚;住所为成都市双流区九江街道通江社区渔江路299号;生产地址为成都市双流区九江街道通江社区渔江路299号;双流区彭镇工业港A区(成都市双楠大道下段1998号);生产范围为2002分类目录Ⅱ类:6856-2-病床2017分类目录Ⅱ类:15-03-医用病床.
产品信息:1电动护理病床川械注准20192150168.
","43769","43769","45595","四川省药品监督管理局","医疗器械生产许可信息通告(2019年第34期)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关","1","《医疗器械生产许可证》增加生产范围/增加生产产品","攀枝花市川美义齿制作有限公司","915104020644598655","樊正萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150053号","住所由四川省攀枝花市东区银江镇华山村老熊箐社(巴斯箐处)171栋2楼变更为攀枝花市仁和区仁和镇仁和新村商业街西6号楼(正商街48号)三楼;定制式固定义齿川注册证号由食药监械(准)字2014第2630019号变更川械注准20172630207.
","43775","43775","44020","四川省药品监督管理局","2","《医疗器械生产许可证》核发","成都天奥电子股份有限公司","9151010075598305X1","徐建平","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190056号","法定代表人为徐建平;企业负责人为郑兴世;住所为成都市金牛区高科技产业开发区土桥村九组;生产地址为成都市金牛区金科东路50号2号楼(7楼702、709、10楼1005、1006);生产范围为2002分类目录Ⅱ类:6821-4-心电诊断仪器2017分类目录Ⅱ类:07-03-生理参数分析测量设备.
","43775","43775","45601","四川省药品监督管理局","3","《医疗器械生产许可证》延续","成都博奥晶芯生物科技有限公司","91510115577375018L","宋云鹏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150041号","法定代表人为宋云鹏;企业负责人为朱宏;住所为成都市温江区永宁镇八一路北段88号;生产地址为成都市温江区永宁镇八一路北段88号3栋-1(1楼118、119,2楼)、3栋-2(3楼)、3栋-3、3栋-4(1楼1-3、E-109,2楼,顶楼3-3至3-5)、4栋(101、103)、5栋;生产范围为2002分类目录Ⅱ类:6840-1-血液分析系统,6840-8-基因和生命科学仪器Ⅲ类:6840-3-免疫分析系统,6840-8-基因和生命科学仪器,6840--体外诊断试剂2017分类目录Ⅱ类:16-04-眼科测量诊断设备和器具,22-10-其他医用分析设备Ⅲ类:22-05-分子生物学分析设备.
","43775","43775","45601","四川省药品监督管理局","4","《医疗器械生产许可证》核发","成都抚南医药有限公司","91510100057499578H","方明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190057号","法定代表人为方明;企业负责人为方明;住所为成都高新区科园南路88号12栋2层204号、205号;生产地址为成都高新区科园南路88号12栋2层204号、205号;生产范围为2002分类目录Ⅱ类:6823-4-其他2017分类目录Ⅱ类:06-08-超声影像诊断附属设备.
","43775","43775","45601","四川省药品监督管理局","5","《医疗器械生产许可证》核发","四川广铭生物制品有限公司","91510681MA623BLC8D","李燕","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190059号","法定代表人为李燕;企业负责人为李燕;住所为四川省广汉市台中路东段74号;生产地址为四川省广汉市台中路东段74号;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-10-创面敷料.
","43775","43775","45601","四川省药品监督管理局","6","《医疗器械生产许可证》核发","四川海汇药业有限公司","91510122062401950W","徐镜人","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190058号","新核发.
法定代表人为徐镜人;企业负责人为施猛;住所为中国(四川)自由贸易试验区成都市双流区西航港大道中四段2899号;生产地址为中国(四川)自由贸易试验区成都市双流区西航港大道中四段2899号3幢、6幢;生产范围为2002分类目录Ⅱ类:6801-1-医用缝合针(不带线)2017分类目录Ⅱ类:02-12-手术器械-穿刺导引器.
","43775","43775","45601","四川省药品监督管理局","7","《医疗器械生产许可证》核发","四川正美齿科科技有限公司","91512000MA691N2079","姚峻峰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190009号","增加生产产品:定制式隐形正畸矫治器沪械注准20192170061受托生产截止于2024年1月14日.
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","43776","43776","44824","四川省药品监督管理局","医疗器械生产许可信息通告(2019年第35期)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关","1","《医疗器械生产许可证》延续","成都市卫生材料厂","9151011220223688X5","曾秀英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150032号","法定代表人为曾秀英;企业负责人为曾群芳;住所为成都经济技术开发区(老成渝公路14公里);生产地址为成都经济技术开发区(老成渝公路14公里);生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料.
","43788","43788","45614","四川省药品监督管理局","2","《医疗器械生产许可证》延续","四川千里倍益康医疗科技股份有限公司","91510108629517429X","张文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150040号","法定代表人为张文;企业负责人为张文;住所为成都市成华区东三环路二段龙潭工业园;生产地址为成都市成华区龙潭工业园成致路6号29栋3单元1-3层1号成都市成华区龙潭工业园成致路6号25栋2单元1-3层1号;生产范围为2002分类目录Ⅱ类:6825-1-高频手术和电凝设备,6826-2-电疗仪器2017分类目录Ⅱ类:09-01-电疗设备/器具,09-02-温热(冷)治疗设备/器具,09-04-力疗设备/器具,20-02-中医治疗设备.
","43788","43788","45614","四川省药品监督管理局","3","《医疗器械生产许可证》延续","绵阳索尼克电子有限责任公司","915107032054004466","付玉瑞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150037号","法定代表人为付玉瑞;企业负责人为付玉瑞;住所为四川省绵阳市长虹大道兴盛街18号;生产地址为四川省绵阳市长虹大道兴盛街18号;生产范围为2002分类目录Ⅱ类:6823-1-超声诊断设备,6823-3-超声治疗设备Ⅲ类:6823-3-超声治疗设备.
","43788","43788","45614","四川省药品监督管理局""4","《医疗器械生产许可证》延续","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","法定代表人为石保社;企业负责人为董合军;住所为成都市新津县新平镇万街村七组46号;生产地址为成都市新津县新平镇万街村七组46号;生产范围为2002分类目录Ⅱ类:6841-4-血液化验设备和器具,6856-1-供氧系统,6864-2-敷料、护创材料,6865-4-表面缝合材料,6866-4-导管、引流管,6866-5-呼吸麻醉或通气用气管插管,6866-6-肠道插管Ⅲ类:6815--注射穿刺器械,6845-4-血液净化设备和血液净化器具,6866-1-输液、输血器具及管路,6866-4-导管、引流管2017分类目录Ⅱ类:02-01-手术器械-刀,14-03-非血管内输液器械,14-05-非血管内导(插)管,14-13-手术室感染控制用品,14-14-医护人员防护用品,14-16-其它器械Ⅲ类:14-02-血管内输液器械,22-11-采样设备和器具.
","43788","43788","45614","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都汇声科技有限公司","915101003320813372","刘刚强","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170018号","法定代表人由熊佑全变更为刘刚强;增加生产范围(2017年分类)Ⅱ类:06-07-超声影像诊断设备;增加生产产品:微型彩色超声诊断系统川械注准20192060193.
","43788","43788","44718","四川省药品监督管理局""6","《医疗器械生产许可证》核发","成都凡迪医疗器械有限公司","91510122MA61RYGA2T","李骏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190060号","法定代表人为李骏;企业负责人为崔书建;住所为中国(四川)自由贸易试验区成都市双流区公兴街道物联东街188号15栋3楼301号;生产地址为中国(四川)自由贸易试验区成都市双流区公兴街道物联东街188号15栋3楼301号、成都市双流区华府大道四段777号感知中国成都中心A3栋第十五层二号房;生产范围为2002分类目录Ⅲ类:6840--体外诊断试剂;注册产品信息:1胎儿染色体非整倍体(T21、T18、T13)检测试剂盒(可逆末端终止测序法)国械注准20193400772体外诊断试剂.
","43788","43788","45614","四川省药品监督管理局""7","《医疗器械生产许可证》延续","成都东方人健康产业有限责任公司","915101827130568803","黄维彪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150021号","法定代表人为黄维彪;企业负责人为黄维彪;住所为成都市彭州市丽春镇黄鹤村五组48号;生产地址为四川省成都市彭州市丽春镇黄鹤村五组48号;生产范围为2002分类目录Ⅱ类:6826-2-电疗仪器,6826-5-理疗康复仪器,6826-7-磁疗仪器.
","43791","43791","45617","四川省药品监督管理局""8","《医疗器械生产许可证》核发","四川省菲娅医疗器械有限公司","91512000MA67838U2F","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190061号","法定代表人为何国昆;企业负责人为李虎;住所为四川省资阳市现代大道3号C栋一、二层C2-E区;生产地址为四川省资阳市现代大道3号C栋一、二层C2-E区;生产范围为2002分类目录Ⅱ类:6863-10-正畸材料2017分类目录Ⅱ类:17-07-口腔正畸材料及制品.
注册产品信息:1镍钛合金牙弓丝川械注准20192170182.
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","43791","43791","45617","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产产品","成都金盘电子科大多媒体技术有限公司","91510100709225442F","曲建明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180035号","增加生产范围(2017年分类)Ⅱ类:21-02-影像处理软件;减少生产产品:GD-PACS临床医学影像通讯与存储系统川械注准20142700002;增加生产产品:临床医学影像通讯与存储系统川械注准20142210002.
","43791","43791","45197","四川省药品监督管理局""11","《医疗器械生产许可证》延续","成都迪康中科生物医学材料有限公司","915101007203615413","李晓萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150048号","法定代表人为李晓萍;企业负责人为李晓萍;住所为成都高新区西部园区迪康大道1号;生产地址为成都高新区西部园区迪康大道1号1幢1F;成都高新区西部园区迪康大道1号1幢2F;成都高新区西部园区迪康大道1号6栋1层1号4F.
生产范围为2002分类目录Ⅱ类:6801-2-一次性使用无菌手术刀,6864-2-敷料、护创材料Ⅲ类:6846-1-植入器材,6864-1-可吸收性止血、防粘连材料2017分类目录Ⅱ类:14-10-创面敷料.
","43791","43791","45617","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","成都艾科斯伦医疗科技有限公司","915101226988525032","夏斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150051号","生产地址非文字性变更由成都市双流区西南航空港经济开发区腾飞二路355号(西南航空港经济开发区孵化园第6栋第3层)变更为成都市双流区西南航空港经济开发区腾飞二路355号(西南航空港经济开发区孵化园第6栋第3层)成都市双流区西南航空港经济开发区腾飞二路355号(西南航空港经济开发区孵化园第13栋第3层);增加生产产品:1N末端脑利钠肽前休(NT-proBNP)检测试剂盒(荧光免疫层析法)川械注准20192400183体外诊断试剂2全程C反应蛋白(CRP)检测试剂盒(荧光免疫层析法)川械注准20192400184体外诊断试剂3中性粒细胞明胶酶相关脂质运载蛋白(NGAL)检测试剂盒(荧光免疫层析法)川械注准20192400185体外诊断试剂4白介素6(IL-6)检测试剂盒(荧光免疫层析法)川械注准20192400186体外诊断试剂5降钙素原(PCT)检测试剂盒(荧光免疫层析法)川械注准20192400187体外诊断试剂6肌钙蛋白I(cTnI)检测试剂盒(荧光免疫层析法)川械注准20192400188体外诊断试剂7β2-微球蛋白(β2-MG)检测试剂盒(荧光免疫层析法)川械注准20192400189体外诊断试剂8心脏型脂肪酸结合蛋白(H-FABP)检测试剂盒(荧光免疫层析法)川械注准20192400190体外诊断试剂9人血清淀粉样蛋白A(SAA)检测试剂盒(荧光免疫层析法)川械注准20192400191体外诊断试剂10胱抑素C(CysC)检测试剂盒(荧光免疫层析法)川械注准20192400192体外诊断试剂.
","43791","43791","43991","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第36期)(截止2019.
12.
6)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》住所变更","成都宏达洁净技术工程有限公司","915101126675518201","张茂","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180028号","住所由四川省成都经济技术开发区(龙泉驿区)成龙大道二段888号E区1栋变更为四川省成都经济技术开发区(龙泉驿区)成龙大道二段888号1栋1层1号、2层1号","43801","43801","45151","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都登特牙科技术开发有限公司","91510122743620809W","蒋安琪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150014号","增加生产范围(2017年分类)Ⅱ类:17-06-口腔义齿制作材料;定制式固定义齿注册证号川食药监械(准)字2014第2630114号变更为川械注准20192170144;定制式活动义齿注册证号川食药监械(准)字2014第2630113号变更为注册证号川械注准20192170145.
","43801","43801","43873","四川省药品监督管理局""3","《医疗器械生产许可证》延续","成都吉泰医疗器械有限公司","91510115551099932J","李雪松","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150062号","法定代表人为李雪松;企业负责人为李雪松;住所为成都市温江区成都海峡两岸科技产业开发园科兴路西段188号;生产地址为成都市温江区科兴路西段188号11栋2楼;生产范围为2002分类目录Ⅱ类:6809-6-一次性使用管型痔吻合器Ⅲ类:6864-2-敷料、护创材料.
","43801","43801","45627","四川省药品监督管理局""4","《医疗器械生产许可证》生产地址非文字性变更","四川明锐医疗器械有限公司","915106815582454887","鲁中华","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160063号","生产地址非文字性变更由四川省广汉市南兴镇东岗村三组变更为四川省德阳市广汉市南兴镇东岗村三组.
","43801","43801","44551","四川省药品监督管理局""5","《医疗器械生产许可证》延续","四川康宁医用器材有限公司","91511126207506236U","朱良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150055号","法定代表人为朱良;企业负责人为朱良;住所为四川省夹江县漹城镇迎春南路;生产地址为四川省夹江县漹城镇迎春南路;生产范围为2002分类目录Ⅱ类:6815--注射穿刺器械Ⅲ类:6815--注射穿刺器械,6866-1-输液、输血器具及管路.
","43801","43801","45627","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第37期)(截止2019.
12.
23)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","成都顺雅医疗用品有限公司","9151012275283864X6","向守香","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180037号","减少生产范围(2002年分类)Ⅱ类:6863-16-定制式义齿类;增加生产范围(2017年分类)Ⅱ类:17-06-口腔义齿制作材料,17-07-口腔正畸材料及制品,生产范围(2002年分类)Ⅱ类:6863-10-正畸材料,6863-16-定制式义齿;增加生产产品:定制式矫治器川械注准20192170181.
","43808","43808","45208","四川省药品监督管理局""2","《医疗器械生产许可证》生产地址非文字性变更","成都方拓仿真技术有限责任公司","91510100725379927T","林涛","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160001号","生产地址非文字性变更由成都市青羊区文家华严工业区6组变更为成都市青羊区工业集中发展区西区第2#地块第B1栋11号;减少生产范围(2002年分类)Ⅱ类:6833-2-放射性核素诊断设备;增加生产范围(2002年分类)Ⅱ类:6831-4-附属设备;生产范围(2017年分类)Ⅱ类:06-05-X射线附属及辅助设备.
","43808","43808","44199","四川省药品监督管理局""3","《医疗器械生产许可证》延续","成都创宜生物科技有限公司","915101005510619933","向阳","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150034号","法定代表人为向阳;企业负责人为范稀;住所为成都高新区科园南路88号天府生命科技园7号研发楼302号;生产地址为成都高新区科园南路88号天府生命科技园7号研发楼302号;生产范围为2002分类目录Ⅱ类:6840--体外诊断试剂.
","43750","43750","45576","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都瑞琦医疗科技有限责任公司","91510100713042665P","韦德","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150036号","一次性使用静脉采血针的注册证号由国械注准20153151742变更为国械注准20153221742;企业名称由成都瑞琦科技实业股份有限公司变更为成都瑞琦医疗科技有限责任公司.
","43809","43809","45575","四川省药品监督管理局""5","《医疗器械生产许可证》延续","成都领翔义齿技术有限公司","915101155589977782","杜斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150002号","法定代表人为杜斌;企业负责人为杜斌;住所为成都市温江区成都海峡两岸科技产业开发园蓉台大道北段388号;生产地址为成都市温江区天府蓉台大道北段388号12#厂房2楼4-8轴;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿.
","43808","43808","45634","四川省药品监督管理局""6","《医疗器械生产许可证》延续","成都市佳颖医用制品有限公司","91510112709256580X","翟庆斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150024号","法定代表人为翟庆斌;企业负责人为翟庆斌;住所为四川省成都市龙泉驿区大面街道五星街138号;生产地址为成都市龙泉驿区大面街道五星街138号;生产范围为2002分类目录Ⅲ类:6845-4-血液净化设备和血液净化器具,6845-6-体液处理设备,6866-1-输液、输血器具及管路.
","43809","43809","45635","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","成都联帮医疗科技股份有限公司","91510100633135511R","谢邦庆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150007号","产品延续注册后注册证号变更.
医用中心供氧系统注册证号由川械注准20142560022变更为川械注准20142080022.
","43809","43809","45448","四川省药品监督管理局""8","《医疗器械生产许可证》住所变更/生产地址文字性变更","四川省智能电子实业有限公司","91510100202076847A","吴洪宇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150073号","生产地址文字性变更由成都市高新区天府大道南段1399号时代天城1号楼22楼2211、2212、2213、2214、2215、2216、2217、2218、2219、2221号变更为成都高新区天府大道南段1399号时代天城1号楼22楼11-19号、21号","43810","43810","44185","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","卡瓦(四川)医疗器械有限公司","91512000MA66NA1L43","侯刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190002号","增加生产范围(2017年分类)Ⅱ类:17-07-口腔正畸材料及制品;增加生产产品:定制式正畸矫治器川械注准20192170211.
","43816","43816","45298","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","四川新世纪医用高分子制品有限公司","91510000201884076F","陈姬","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150047号","减少生产范围:Ⅲ类:6846-1-植入器材,6866-1-输液、输血器具及管路;减少生产产品:医用聚丙烯疝修补网、一次性使用分装输液器带针增加生产范围:Ⅲ类:13-09-整形及普通外科植入物,14-02-血管内输液器械;增加生产产品:医用聚丙烯疝修补网、一次性使用袋式输液器带针.
","43819","43819","43989","四川省药品监督管理局""医疗器械生产许可信息通告(2019年第38期)(截止2019.
12.
27)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》延续","成都登特牙科技术开发有限公司","91510122743620809W","蒋安琪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150014号","同意延续.
法定代表人为蒋安琪;企业负责人为朱刚;住所为成都市双流区西南航空港经济开发区腾飞二路355号第二栋;生产地址成都市双流区西南航空港经济开发区腾飞二路355号第二栋;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿;2017年分类目录Ⅱ类:17-06-口腔义齿制作材料","43824","43824","45650","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第1期)(截止2020.
1.
9)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》核发","成都德而塔生物科技有限公司","91510100MA61T9255K","王俊","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200001号","新核发.
住所为成都高新区益州大道722号1栋1单元2005-2006;生产地址为成都市高新区合宁路288号3号楼5楼;法定代表人为王俊;企业负责人为王俊.
生产范围为2002年分类目录:Ⅱ类:Ⅱ类:6823-4-其他;2017年分类目录:Ⅱ类:09-08-其他物理治疗设备.
","43837","43837","45663","四川省药品监督管理局""2","《医疗器械生产许可证》核发","成都朴华科技有限公司","9151010059205081X5","刘畅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200002号","新核发.
住所为成都高新区高朋大道5号1幢206室;生产地址为成都高新区高朋大道5号2栋102室;法定代表人为刘畅;企业负责人为刘畅.
生产范围为2002年分类目录:Ⅱ类:6840-5-尿液分析系统;2017年分类目录:Ⅱ类:22-09-尿液及其他样本分析设备.
","43837","43837","45663","四川省药品监督管理局""3","《医疗器械生产许可证》核发","斯派丹(四川)口腔医疗器械有限公司","91512000MA627URB15","AHNJEMO","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200003号","新核发.
住所为四川省资阳市现代大道3号A栋二层D、E、F区;生产地址为四川省资阳市现代大道3号A栋二层D、E、F区;法定代表人为AHNJEMO;企业负责人为AHNJEMO.
生产范围为2002年分类目录:Ⅱ类:6863-9-充填辅助材料;2017年分类目录:Ⅱ类:17-09-口腔治疗辅助材料.
","43838","43838","45664","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","四川千里倍益康医疗科技股份有限公司","91510108629517429X","张文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150040号","减少生产范围/生产产品,产品延续注册后注册证号变更.
减少生产范围:Ⅱ类:6825-1-高频手术和电凝设备.
减少生产产品:经皮神经电刺激仪、痉挛肌低频治疗仪、神经肌肉电刺激仪、高频肛肠治疗机、高频妇科治疗机.
痉挛肌低频治疗仪注册证号由"川食药监械(准)字2014第2260137号"变更为"川械注准20192090217"、经皮神经电刺激仪注册证号由"川食药监械(准)字2014第2260135号"变更为"川械注准20192090218"、神经肌肉电刺激仪注册证号由"川食药监械(准)字2014第2260136号"变更为"川械注准20192090219".
","43839","43839","45614","四川省药品监督管理局""5","《医疗器械生产许可证》法定代表人变更","四川空分医用设备工程股份有限公司","91512081206850713M","黄凯","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150065号","法定代表人由"黄一贵"变更为"黄凯".
","43839","43839","44079","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第2期)(截止2020.
1.
19)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150057号","增加生产产品:一次性使用精密过滤输液器带针(注册证号:国械注准20193140803).
一次性使用精密过滤袋式输液器注册证号由"国械注准20143662285"变更为"国械注准20143142285"、一次性使用袋式输液器带针注册证号由"国械注准20143662279"变更为"国械注准20143142279"、自毁式一次性使用无菌注射器带针注册证号由"国械注准20143152277"变更为"国械注准20143142277"、一次性使用无菌注射针注册证号由"国械注准20143152282"变更为"国械注准20143142282"、一次性使用采血针注册证号由"国械注准20143152283"变更为"国械注准20143222283"、一次性使用人体静脉血样真空采集容器注册证号由"川械注准20142410031"变更为"川械注准20142220031"、一次性使用无菌溶药器注册证号由"川械注准20152150037"变更为"川械注准20152140037"、一次性使用无菌溶药针注册证号由"川械注准20152150036"变更为"川械注准20152140036"、一次性使用输氧管注册证号由"川械注准20142560006"变更为"川械注准20142080006"、呼吸回路注册证号由"川械注准20142660004"变更为"川械注准20142080004"、非调和型口腔正畸粘接剂注册证号由"川械注准20142630012"变更为"川械注准20142170012"、一次性使用管型痔吻合器注册证号由"川械注准20142090008"变更为"川械注准20142020008"、一次性使用管型消化道吻合器注册证号由"川械注准20142080009"变更为"川械注准20142020009".
","43843","43843","44045","四川省药品监督管理局""2","《医疗器械生产许可证》延续","四川新世纪医用高分子制品有限公司","91510000201884076F","陈姬","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150047号","延续.
法定代表人为陈姬,企业负责人为陈姬.
住所为成都市望平街2号望平大厦四楼,生产地址为成都市龙泉驿区大面东洪路199号.
2002年分类目录:Ⅱ类:6815--注射穿刺器械Ⅲ类:6815--注射穿刺器械,6846-1-植入器材,6866-1-输液、输血器具及管路2017年分类目录:Ⅲ类:13-09-整形及普通外科植入物,14-02-血管内输液器械.
","43843","43843","45669","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都瑞琦医疗科技有限责任公司","91510100713042665P","韦德","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150036号","产品延续注册后注册证号变更.
一次性使用静脉采血针注册证号由"国械注准20153151742"变更为"国械注准20153221742".
","43846","43846","45575","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","南充市顺庆区艺美义齿加工中心","91511302MA6290H824","曾建君","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160023号","产品延续注册后注册证号变更.
定制式固定义齿注册证号由"川食药监械(准)字2014第2630022号"变更为"川械注准20172630247";定制式活动义齿注册证号由"川食药监械(准)字2014第2630023号"变更为"川械注准20172630248".
","43846","43846","44304","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川阿尔泰医疗器械有限公司","91510681665385216T","黄永兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160025号","增加生产产品:交锁髓内钉(注册证号:国械注准20193130733).
","43846","43846","44307","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新兴内窥镜科技有限公司","915101082022156674","王传林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150043号","产品延续注册后注册证号变更.
电子腹腔内窥镜延续注册后,注册证号由"国食药监械(准)字2014第3221426号"变更为"国械注准20193061662";医用内窥镜冷光源注册证号由"川食药监械(准)字2013第2220030号"变更为"川械注准20192060106";鼻窦镜注册证号由"川食药监械(准)字2014第2220120号"变更为"川械注准20192060175";内窥镜摄录像系统注册证号由"川食药监械(准)字2014第2220096号"变更为"川械注准20192060149";尿道膀胱镜注册证号由"川食药监械(准)字2014第2220119号"变更为"川械注准20192060177";冲洗吸引仪注册证号由"川食药监械(准)字2014第2540153号"变更为"川械注准20192060195";CO2气腹仪注册证号由"川械注准20152210017"变更为"川械注准20152060017".
","43847","43847","43968","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","绵阳立德电子股份有限公司","91510700717509138R","文云洋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150003号","产品延续注册后注册证号变更.
射频消融仪注册证号由"国械注准20143252220"变更为"国械注准20143012162;射频治疗仪注册证号由"国械注准20143252220"变更为"国械注准20143012220".
","43847","43847","45503","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:1、直接胆红素测定试剂盒(氧化法)(川械注准20192400206);2、载脂蛋白E测定试剂盒(免疫比浊法)(川械注20192400196);3、小而密低密度脂蛋白胆固醇测定试剂盒(过氧化物酶法)(川械注准20192400204);4、抗环瓜氨酸肽抗体质控品(川械注准20192400205);5、抗环瓜氨酸肽抗体测定试剂盒(直接化学发光法)(川械注准20192400216);6、超敏C-反应蛋白测定试剂盒(胶乳免疫比浊法)(川械注准20192400207);7、胱抑素C质控品(川械注准20192400215).
","43847","43847","44067","四川省药品监督管理局""9","《医疗器械生产许可证》核发","资阳思迈欧科技有限公司","91512000MA648R0T6L","保占波","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200004号","新核发.
法定代表人为保占波;企业负责人为保占波;住所为四川省资阳市现代大道3号C栋四楼B2、C1区;生产地址为四川省资阳市现代大道3号C栋四楼B2、C1区;生产范围为2002分类目录Ⅱ类:6855-1-口腔综合治疗设备2017分类目录Ⅱ类:17-03-口腔治疗设备.
产品信息:局部麻醉助推仪川械注准20202170009.
","43849","43849","45675","四川省药品监督管理局""10","《医疗器械生产许可证》核发","四川鸿政博恩口腔科技有限公司","91512000MA675NEL5M","王立新","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200005号","新核发.
法定代表人为王立新;企业负责人为林政纬;住所为四川省资阳市现代大道3号B栋一层B区;生产地址为四川省资阳市现代大道3号B栋一层B区;生产范围为2002分类目录Ⅱ类:6855-6-车针2017分类目录Ⅱ类:17-04-口腔治疗器具.
产品信息:种植手术用牙钻川械注准20202170005.
","43849","43849","45675","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第3期)(截止2020.
3.
2)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川锦江电子科技有限公司","915101077348059327","李楚文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150016号","增加生产产品:一次性使用心脏射频消融导管(注册证号:国械注准20203010014)","43851","43851","45484","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150057号","减少生产产品一次性使用连通管,川械注准20142660007;一次性使用手术刀,川械注准20142010020;减少生产范围:6801-2-一次性使用无菌手术刀,6866-4-导管、引流管.
","43851","43851","44045","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市卫生材料厂","9151011220223688X5","曾秀英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150032号","产品延续注册后注册证号变更:医用脱脂棉注册证号由川食药监械(准)字2014第2640159号变更为川械注准20192140158;增加生产范围2017年分类目录:Ⅱ类:14-09-不可吸收外科敷料","43853","43853","45614","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都明森医疗器械有限责任公司","91510100743635584L","何德兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170011号","增加生产产品:外科纱布敷料,川械注准20202140011;医用腹巾,川械注准20202140012;一次性使用透析护理包,川械注准20202140013;增加生产范围:(2017年分类)Ⅱ类:14-09-不可吸收外科敷料,14-14-医护人员防护用品","43853","43853","44642","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川康博医疗器械有限公司","91511422553468535D","左兰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170013号","增加生产产品:一次性使用医用口罩,注册证号为川械注准20202140018;增加生产范围2017年分类目录:Ⅱ类:14-13-手术室感染控制用品","43858","43858","44689","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","自贡市济生医用器材有限责任公司","9151030471752723XN","肖正荣","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170006号","一次性使用医用口罩延续注册,注册证号川械注准20152640032变更为川械注准20152140032;一次性使用医用手术帽延续注册后产品名称变更为一次性使用医用帽,注册证号码由川食药监械(准)字2014第2640062号变更为川械注准20182640086;增加生产范围2017年分类目录:Ⅱ类:14-13-手术室感染控制用品.
","43858","43858","44625","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","减少一次性使用安全采血针,许可证证号鲁食药监械(准)字2012第2410475号,受托生产2016年11月1日;医用外科口罩的注册证号由川械注准20152640045变更为川械注准20152140045;增加生产产品:一次性使用输液器带针注册证号为国械注准20193140729;一次性使用袋式输液器带针注册证号为国械注准20193140730;一次性使用精密过滤输液器带针注册证号为国械注准20193140732;一次性使用精密过滤袋式输液器带针注册证号为国械注准20193140734.
","43859","43859","45614","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市卫生材料厂","9151011220223688X5","曾秀英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150032号","增加生产产品一次性使用医用口罩(川械注准20202140019),增加生产范围2017年分类目录:Ⅱ类:14-13-手术室感染","43859","43859","45614","四川省药品监督管理局""9","《医疗器械生产许可证》核发","四川优可得医疗器械有限公司","91510700MA6BBMHQ94","陈华英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200006号","新核发.
法定代表人为陈华英;企业负责人为罗金龙;住所为绵阳高新区飞云大道东段261号绵阳出口加工区关外第102幢北翼第二层;生产地址为绵阳高新区飞云大道东段261号绵阳出口加工区关外第102幢北翼第二层;生产范围为2002分类目录Ⅱ类:6820-1-体温计2017分类目录Ⅱ类:07-03-生理参数分析测量设备.
产品信息:红外体温计川械注准20202070020.
","43860","43860","45686","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克医疗电子有限公司","91510100590236741G","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170038号","增加生产产品:糖化血红蛋白分析仪,川械注准20192220222;全自动化学发光免疫分析仪,川械注准20202220015;全自动血细胞分析仪,川械注准20202220016;增加生产范围:(2017年分类)22-01-血液学分析设备,22-04-免疫分析设备,22-10-其他医用分析设备","43860","43860","44874","四川省药品监督管理局""11","《医疗器械生产许可证》延续","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","同意延续.
住所为成都市高新区百川路16号;生产地址为成都市高新区百川路16号成都市高新区安和二路8号5栋1-5层;法定代表人为唐勇为企业负责人为吴明建;生产范围(2002年分类)Ⅱ类:6840--体外诊断试剂Ⅲ类:6840--体外诊断试剂.
","43861","43861","45687","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","四川锦江电子科技有限公司","915101077348059327","李楚文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150016号","增加生产产品:1、一次性使用固定弯型心脏电生理标测导管(国械注准20203070027);2一次性使用可调弯型心脏电生理标测导管(国械注准20203070026).
增加生产范围:2017年分类:Ⅲ类07-10-、耗材.
","43865","43865","45484","四川省药品监督管理局""13","《医疗器械生产许可证》延续","成都艾科斯伦医疗科技有限公司","915101226988525032","夏斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150051号","同意延续.
住所为成都市双流区西南航空港经济开发区腾飞二路355号;生产地址为成都市双流区西南航空港经济开发区腾飞二路355号(西南航空港经济开发区孵化园第6栋第3层)成都市双流区西南航空港经济开发区腾飞二路355号(西南航空港经济开发区孵化园第13栋第3层);法定代表人为夏斌;企业负责人为夏斌.
分类目录为2002年分类:Ⅱ类:6840-1-血液分析系统,6840--体外诊断试剂,6864-2-敷料、护创材料.
","43865","43865","45691","四川省药品监督管理局""14","应急审批","际华三五三六实业有限公司","915107002054124399","喻量","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200001号","应急核发.
法定代表人为喻量;企业负责人为喻量;住所为绵阳高新区磨家工业园;生产地址绵阳市阴平路63号2#楼2层;生产范围2017分类目录Ⅱ类:14-14医护人员防护用品.
产品信息:医用一次性防护服川械注应急准20202140001.
","43870","43870","至国家宣布疫情解除","四川省药品监督管理局""15","应急审批","四川省遂宁市康达卫生材料有限公司","91510900708990468B","刘亚西","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200002号","应急核发.
法定代表人为刘亚西;企业负责人为刘亚西;住所为遂宁市创新工业园区南津南路14号;生产地址为遂宁市创新工业园区南津南路14号3栋;生产范围2017分类目II类:14-13-手术室感染控制用品.
产品信息:一次性使用医用口罩川械注应急准20202140002.
","43871","43871","至国家宣布新型冠状病毒感染肺炎疫情解除","四川省药品监督管理局""16","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","增加生产产品:一次性使用压力延长管(注册证号:国械注准20193141059)","43871","43871","45614","四川省药品监督管理局""17","应急审批","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200004号","应急核发.
住所为成都市新津县新平镇万街村七组46号;法定代表人为石保社为;企业负责人为董合军为;生产地址非文字性变更为成都市新津县新平镇万街村七组46号;生产范围(2017年分类)II类14-01防护口罩;产品信息:医用防护口罩,川械注应急准20202140004.
","43874","43874","至国家宣布新型冠状病毒感染肺炎疫情解除","四川省药品监督管理局""18","应急审批","四川杏林医疗器械有限公司","91510521595090294H","童世兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200005号","应急核发.
法定代表人为童世兵;企业负责人为邱有才;生产地址为泸县玉蟾街道怡园路西段5号1-4幢;住所为泸县城西工业园B区;生产范围(2017年分类)Ⅱ类:14-13手术室感染控制用品;产品信息:1医用外科口罩为川械注应急准20202140005;2一次性使用医用口罩为川械注应急准20202140006.
","43875","43875","44056","四川省药品监督管理局""19","应急审批","成都康惠净科技有限公司","91510100698859916R","LeeYuuTang(李有冬)","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200006号","应急核发.
住所为四川省成都市郫都区成都现代工业港港北六路106号;生产地址为四川省成都市郫都区成都现代工业港港北六路106号;法定代表人为LeeYuuTang(李有冬);企业负责人为王渊;生产范围2017分类目II类:14-13手术室感染控制用品;产品信息:1一次性使用医用口罩为川械注应急准20202140007;2医用外科口罩川械注应急准20202140008.
","43878","43878","44059","四川省药品监督管理局""20","应急审批","四川恒明科技开发有限公司","915101067559967907","廖佳明","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200008号","应急核发.
住所为四川省彭州工业开发区天彭镇旌旗西路39号;生产地址为四川省彭州工业开发区天彭镇旌旗西路39号4#、8#;法定代表人为廖佳明;企业负责人为张仕川;生产范围2017分类目II类:14-13手术室感染控制用品;产品信息:医用外科口罩为川械注应急准20202140010.
","43880","43880","44061","四川省药品监督管理局""21","《医疗器械生产许可证》增加生产范围/增加生产产品","成都欧赛医疗器械有限公司","91510122768647821B","甘释良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150011号","增加生产产品中空纤维膜血液透析器,国械注准20203100056.
","43882","43882","43856","四川省药品监督管理局""22","《医疗器械生产许可证》增加生产范围/增加生产产品","四川海汇药业有限公司","91510122062401950W","徐镜人","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190058号","增加生产产品:1、一次性使用呼吸过滤器(川械注准20202020001);2、一次性使用泌尿道斑马导丝(川械注准20202020002)","43865","43865","45296","四川省药品监督管理局""23","《医疗器械生产许可证》核发","成都优材科技有限公司","91510100332005959B","蒋安琪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200011号","新核发.
法定代表人为蒋安琪;企业负责人为曾益伟住所为成都高新区科园南二路1号9幢1层A座;生产地址为成都高新区科园南二路1号9幢1层A座;生产范围为2002分类目录Ⅱ类:6863-7-金属、陶瓷类义齿材料2017分类目录Ⅲ类:17-06-口腔义齿制作材料;产品信息:牙科激光选区熔化钛合金粉末为国械注准20203170037.
","43882","43882","45708","四川省药品监督管理局""24","《医疗器械生产许可证》增加生产范围/增加生产产品","成都博奥晶芯生物科技有限公司","91510115577375018L","宋云鹏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150041号","增加生产产品六项呼吸道病毒核酸检测试剂盒(恒温扩增芯片法),国械注准20203400178.
","43885","43885","45601","四川省药品监督管理局""25","应急审批","四川省遂宁市康达卫生材料有限公司","91510900708990468B","刘亚西","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200002号","增加生产产品:医用外科口罩,川械注应急准20202140011.
","43882","43882","44063","四川省药品监督管理局""26","应急审批","四川普瑞斯生物科技有限公司","91511503563252148F","雷冰","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200011号","应急核发.
住所为宜宾市南溪区罗龙工业园区普瑞斯路2号;生产地址为宜宾市南溪区罗龙工业园区普瑞斯路2号;法定代表人为雷冰;企业负责人为李竞;生产范围2017分类目II类14-01防护口罩;产品信息:医用防护口罩川械注应急准20202140015","43889","43889","44070","四川省药品监督管理局""27","应急审批","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200004号","增加生产产品:医用一次性防护服川械注应急准20202140016","43889","43889","44070","四川省药品监督管理局""28","《医疗器械生产许可证》增加生产范围/增加生产产品","成都爱兴生物科技有限公司","915101000643341495","包德泉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190001号","增加生产产品:1、胃蛋白酶原Ⅰ测定试剂盒(均相化学发光免疫分析法)(注册证号:川械注准20192400202);2、胃蛋白酶原Ⅱ测定试剂盒(均相化学发光免疫分析法)(注册证号:川械注准20192400203);3、胱抑素C测定试剂盒(均相化学发光免疫分析法)(注册证号:川械注准20192400200);4、白介素6测定试剂盒(均相化学发光免疫分析法)(注册证号:川械注准20192400201).
","43865","43865","45298","四川省药品监督管理局""29","《医疗器械生产许可证》增加生产范围/增加生产产品","四川海汇药业有限公司","91510122062401950W","徐镜人","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190058号","增加生产产品:1、一次性使用呼吸过滤器(川械注准20202020001);2、一次性使用泌尿道斑马导丝(川械注准20202020002)","43865","43865","45296","四川省药品监督管理局""30","《医疗器械生产许可证》增加生产范围/增加生产产品","成都顺雅医疗用品有限公司","9151012275283864X6","向守香","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180037号","产品延续注册后注册证号变更.
1、定制式固定义齿注册证号由"川械注准20142630017"变更为"川械注准20142170017";2、定制式活动义齿注册证号由"川械注准20142630018"变更为"川械注准20142170018"","43865","43865","45208","四川省药品监督管理局""31","《医疗器械生产许可证》增加生产范围/增加生产产品","四川大学生物材料工程研究中心","91510100201990565A","张兴栋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150049号","减少生产产品:人工髋关节(国食药监械(准)字2014第3461566号);减少生产范围:Ⅲ类:6863-3-根管充填材.
增加生产产品:羟基磷灰石粉料(国械注准20153630860)产品.
延续注册后注册证号变更:1、骨诱导磷酸钙生物陶瓷延续注册后,注册证号由"国食药监械(准)字2014第3460168号"变更为"国械注准20173464518";2、羟基磷灰石生物陶瓷延续注册后,注册证号由"国食药监械(准)字2013第3460314号"变更为"国械注准20173460346";3、牙种植体延续注册后,注册证号由"国食药监械(准)字2014第3461566号"变更为"国械注准20183631641".
","43865","43865","43989","四川省药品监督管理局""32","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省广元市康康医疗器械有限公司","915108007298019616","陈晓英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150072号","减少生产产品:一次性使用输液器带针(国食药监械(准)字2014第3661001号).
一次性使用高压造影注射器及延续注册后,注册证号由"国食药监械(准)字2014第3661170号"变更"国械注准20193061062".
生产地址文字性变更:由"广元市朝天区中子工业园区国储1085号宗地"变更为"广元市朝天区中子镇中曾路10号".
","43865","43865","44147","四川省药品监督管理局""33","《医疗器械生产许可证》核发","四川涑爽医疗用品有限公司","91512000MA64862P9W","肖丽娟","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200009号","新核发.
住所为四川省资阳市现代大道3号A栋三层D、E、F区;四川省资阳市现代大道3号A栋三层D、E、F区;法定代表人为肖丽娟;企业负责人为肖丽娟.
生产范围为2002年分类目录:Ⅱ类:6863-9-充填辅助材料.
2017年分类目录:Ⅱ类:17-09-口腔治疗辅助材料.
","43865","43865","45691","四川省药品监督管理局""34","《医疗器械生产许可证》核发","四川美观达义齿科技有限公司","91510100MA6CG2UK6F","朱新","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200008号","新核发.
住所为成都高新区合瑞南路10号;成都高新区合瑞南路10号1栋4楼(左边);法定代表人为朱新;企业负责人为朱新.
生产范围为2002年分类目录:Ⅱ类:6863-16-定制式义齿.
2017年分类目录:Ⅱ类:17-06-口腔义齿制作材料.
","43865","43865","45691","四川省药品监督管理局""35","《医疗器械生产许可证》核发","四川滋兴生物科技有限公司","91510923MA676T6L60","黄明英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200007号","新核发.
住所为大英县工业集中发展区嘉创产业园17栋标准厂房;大英县工业集中发展区嘉创产业园17栋标准厂房二层生产车间);法定代表人为黄明英;企业负责人为张高顺.
生产范围为2002年分类目录:Ⅱ类:6826-5-理疗康复仪器.
2017年分类目录:Ⅱ类:09-02-温热(冷)治疗设备/器具.
","43865","43865","45691","四川省药品监督管理局""36","应急审批","四川省宜宾圣山服装家纺有限公司","915115007208716484","王健","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200003号","增加生产产品:医用一次性防护服川械注应急准20202140014","43889","43889","44070","四川省药品监督管理局""37","应急审批","四川三和医用材料有限公司","91510121746435609C","梁毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200012号","应急核发.
住所为成都市金堂县赵镇金广路;生产地址为成都市金堂县赵镇金广路;法定代表人为梁毅;企业负责人为梁旭;生产范围:2017分类目II类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩,川械注应急准20202140017;医用外科口罩,川械注应急准20202140018.
","43889","43889","44070","四川省药品监督管理局""38","应急审批","广安康盾医疗器械有限公司","91511621MA64TRJG5Q","蒋维业","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200013号","应急核发.
住所:四川省广安市岳池县经开区科伦路1号;生产地址:四川省广安市岳池县九龙镇体育路248、250及2至8层办公楼;法定代表人为蒋维业;企业负责人为蒋维业;生产范围:2017分类目II类14-13-手术室感染控制用品;产品信息:一次性使用医用口罩,川械注应急准20202140019.
","43889","43889","44070","四川省药品监督管理局""39","应急审批","四川丙寅医疗器械有限公司","91511402MA66WY30XB","刘圣君","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200014号","应急核发.
住所:四川省眉山经济开发区新区本草大道南段10号鑫和工业园E2栋;生产地址:四川省眉山经济开发区新区本草大道南段10号鑫和工业园E2栋;法定代表人为刘圣君;企业负责人为刘圣君;生产范围:2017分类目录Ⅱ类:14-14医护人员防护用品;产品信息:医用一次性防护服,川械注应急准20202140020.
","43889","43889","44070","四川省药品监督管理局""40","《医疗器械生产许可证》增加生产范围/增加生产产品","成都互邦医疗器械有限公司","91510121569682587Y","贺金明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150030号","增加受托生产产品钢管手动轮椅车,沪械注准20172560371,受托生产截止于2022年6月7日;铝合金手动轮椅车,沪械注准20172560373,受托生产截止于2022年6月7日.
","43889","43889","45617","四川省药品监督管理局""41","《医疗器械生产许可证》增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","弓形虫IgM抗体质控物(化学发光法)(注册证号:国械注准20153400442)产品名称变更为弓形虫IgM抗体质控品(化学发光法);增加生产产品:总胆红素测定试剂盒(氧化法),川械注准20192400220;脂蛋白(a)测定试剂盒(胶乳免疫比浊法),川械注准20192400224;尿酸测定试剂盒(尿酸酶法),川械注准20192400226;新型冠状病毒2019-nCoV核酸检测试剂盒(荧光PCR法),国械注准20203400184.
","43892","43892","45687","四川省药品监督管理局""42","《医疗器械生产许可证》企业名称变更","成都科飞达医疗器械有限公司","91510124057458813F","罗毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170003号","企业名称由"成都科飞达医疗器械有限公司"变更为"四川科弘医疗器械有限公司"","43892","43892","44583","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第4期)(截止2020.
3.
16)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","应急审批","四川艾医生医疗科技有限公司","9151011539447032X1","唐迎波","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200010号","新增产品:医用外科口罩,川械注应急准20202140013.
","43886","43886","44067","四川省药品监督管理局""2","《医疗器械生产许可证》法定代表人变更","成都普什医药塑料包装有限公司","91510100785423440P","袁文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150046号","法定代表人由"袁文"变更为"俞文骥".
","43881","43881","45652","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川南格尔生物科技有限公司","91510185071405021T","刘仁明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160004号","产品延续注册后注册证号变更.
血浆采集机延续注册后,注册证号由"国械注准20153450501"变更为"国械注准20153100501";血液成份分离机延续注册后,注册证号由"国械注准20153451174"变更为"国械注准20153101174".
","43881","43881","44199","四川省药品监督管理局""4","《医疗器械生产许可证》核发","成都科奥达光电技术有限公司","9151010071604368XX","曾肖阳","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200012号","新核发.
住所为成都高新区九兴大道六号高发大厦;生产地址为成都双流西航港街道长城路一段187号二楼201-203室,205-211室,216室;法定代表人为曾肖阳;企业负责人为方亦可.
生产范围为2002年分类目录:Ⅱ类:6822-4-眼科光学仪器,6822-6-医用手术及诊断用显微设备.
","43886","43886","45712","四川省药品监督管理局""5","《医疗器械生产许可证》企业住所变更","成都比特律动科技有限责任公司","91510100342979124P","陈旻","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170031号","住所由成都高新区天府大道北段1480号1栋A座2层2附1、2号变为更中国(四川)自由贸易试验区成都高新区世纪城南路599号6栋5层505号.
","43896","43896","44810","四川省药品监督管理局""6","《医疗器械生产许可证》延续","四川长新生物科技有限公司","91510700567603785J","盛瑛","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150050号","同意延续.
住所为绵阳高新区虹盛路1号;生产地址为绵阳市高新区虹盛路1号3栋办公楼4-5层;法定代表人为盛瑛;企业负责人为盛瑛.
生产范围:2002年分类目录:Ⅱ类:6840--体外诊断试剂.
","43866","43866","45692","四川省药品监督管理局""7","《医疗器械生产许可证》延续","四川新奥洁医疗器械有限公司","91510000694839010N","冯彪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150054号","同意延续.
住所为成都市成华区新鸿南路86号25幢2楼;生产地址为四川省成都龙潭总部经济城华冠路192号菲斯特企业园1栋附4号;法定代表人为冯彪;企业负责人为冯兵.
生产范围:2002年分类目录:Ⅱ类:6854-6-负压吸引装置,6856-1-供氧系统,6857-6-专用消毒设备.
","43866","43866","45692","四川省药品监督管理局""8","《医疗器械生产许可证》生产地址非文字性变更","四川君健万峰医疗器械有限责任公司","91510100095267188W","佟光敏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180029号","生产地址非文字性变更由"成都市青羊区腾飞大道189号12栋4楼"变更为"成都市温江区成都海峡两岸科技产业开发园蓉台大道北段388号"海峡中小企业孵化园"1期1栋2楼";住所由"成都市青羊区腾飞大道189号12栋4楼、5楼"变更为"成都市温江区成都海峡两岸科技产业开发园蓉台大道北段388号"海峡中小企业孵化园"1期1栋2楼".
","43866","43866","45160","四川省药品监督管理局""9","《医疗器械生产许可证》延续","成都天田医疗电器科技有限公司","91510114713063028T","姜天华","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150035号","同意延续.
住所为成都市新都区军屯工业集中区;生产地址为成都市新都区军屯工业集中区雷大村1组100号3栋厂房;法定代表人为姜天华;企业负责人为姜天华.
生产范围:2002年分类目录:Ⅱ类:6857-4-干热灭菌设备,6857-6-专用消毒设备.
","43866","43866","45692","四川省药品监督管理局""10","《医疗器械生产许可证》生产地址非文字性变更","成都市九九医疗设备有限公司","915101137587692354","钟盛玖","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180039号","生产地址非文字性变更由"成都市青白江区华金大道一段500号3#厂房"变更为"成都市青白江区同心大道1409号1号厂房4车间";住所由"成都市青白江区华金大道一段500号"变更为"成都市青白江区同心大道1409号".
","43871","43871","45217","四川省药品监督管理局""11","《医疗器械生产许可证》增加生产范围/增加生产产品","成都欧赛医疗器械有限公司","91510122768647821B","甘释良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150011号","增加生产产品:中空纤维膜血液透析器,国械注准20203100056;增加生产范围:2017年分类目录:Ⅲ类:10-02-血液分离、处理、贮存器具.
","43871","43871","45516","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","卡瓦(四川)医疗器械有限公司","91512000MA66NA1L43","侯刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190002号","增加生产产品:牙科种植机,川械注准20202170003.
","43871","43871","45298","四川省药品监督管理局""13","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省菲娅医疗器械有限公司","91512000MA67838U2F","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190061号","增加生产产品:机用镍钛锉,川械注准20202170004;增加生产范围:2017年分类目录:Ⅱ类:17-04-口腔治疗器具.
","43871","43871","45617","四川省药品监督管理局""14","《医疗器械生产许可证》延续","成都美益达医疗科技有限公司","915101000600892974","张晓金","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150045号","同意延续.
住所为成都高新区天映路102号;生产地址为成都高新区天映路102号(主楼)四楼;法定代表人为张晓金;企业负责人为张晓金.
生产范围:2002年分类目录:Ⅱ类:6823-4-其他,6864-2-敷料、护创材料.
","43871","43871","45697","四川省药品监督管理局""15","《医疗器械生产许可证》核发","四川优维康科技发展有限公司","91510100MA63L4MD21","冯雪平","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200010号","新核发.
住所为四川省成都市天府新区新兴街道天工大道916号A1栋2-4层;生产地址为四川省成都市天府新区新兴街道天工大道916号A1栋2楼;法定代表人为冯雪平;企业负责人为冯雪平.
生产范围为2002年分类目录:Ⅱ类:6821-9-无创监护仪器;2017年分类目录:Ⅱ类:07-03-生理参数分析测量设备.
","43871","43871","45697","四川省药品监督管理局""16","应急审批","四川海汇药业有限公司","91510122062401950W","徐镜人","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200009号","新增产品:医用防护口罩,川械注应急准202021400121.
","43886","43886","44067","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第5期)(截止2020.
3.
20)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","应急审批","四川制药制剂有限公司","91510100777457202W","沈山","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200015号","新核发.
住所为成都市高新西区百叶路18号;生产地址为四川省成都市高新西区百叶路18号802一层口罩生产车间,201三、四层;法定代表人为沈山;企业负责人为梅圣亮;生产范围2017分类目II类:14-13-手术室感染控制用品;产品信息:1一次性使用医用口罩川械注应急准202021400222医用外科口罩川械注应急准20202140023.
","43906","43906","44089","四川省药品监督管理局""2","应急审批","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200016号","新核发.
住所为天府新区仁寿视高经济开发区兴园路;生产地址为天府新区仁寿视高经济开发区兴园路;法定代表人为陆盘兴;企业负责人为陆盘中;生产范围2017分类目II类:14-13-手术室感染控制用品;产品信息:1一次性使用医用口罩川械注应急准202021400242医用外科口罩川械注应急准20202140025.
","43906","43906","44089","四川省药品监督管理局""3","《医疗器械生产许可证》企业名称变更","斯派丹(四川)医疗器械有限公司","91512000MA627URB15","AHNJEMO","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200003号","企业名称由斯派丹(四川)口腔医疗器械有限公司变更为斯派丹(四川)医疗器械有限公司.
","43908","43908","45664","四川省药品监督管理局""4","《医疗器械生产许可证》生产地址非文字性变更","成都心吉康科技有限公司","91510100MA61UFJ124","李楚森","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190053号","住所由中国(四川)自由贸易试验区成都高新区天府大道中段萃华路89号1栋1单元7层703号变更为中国(四川)自由贸易试验区成都高新区天府三街69号1栋12层1209号;生产地址非文字性变更由中国(四川)自由贸易试验区成都高新区天府大道中段萃华路89号1栋1单元7层703号变更为中国(四川)自由贸易试验区成都高新区天府三街69号1栋12层1209号.
","43908","43908","45575","四川省药品监督管理局""5","应急审批","四川省伊洁士医疗科技有限公司","91510681771226542D","李天林","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200017号","新核发.
住所为四川省德阳市广汉市小汉工业园区;生产地址为四川省德阳市广汉市小汉工业园区;法定代表人为李天林;企业负责人为李天林;生产范围2017分类目II类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩川械注应急准20202140026.
","43908","43908","44091","四川省药品监督管理局""6","应急审批","成都仁天医疗器械有限公司","91510114399143002H","王强","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200018号","新核发.
住所为成都市新都工业东区君跃路169号金荷工业产业园2号研发车间第三层;生产地址为成都市新都工业东区君跃路169号金荷工业产业园2号研发车间第三层;法定代表人为王强;企业负责人为王强;生产范围2017分类目II类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩川械注应急准20202140027医用外科口罩川械注应急准20202140028.
","43908","43908","44091","四川省药品监督管理局""7","应急审批","四川蓉康世圣药业有限责任公司新都分公司","91510114782692020R","严玲","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200019号","新核发.
住所为成都市新都区三河街道互助社区二社;生产地址为成都市新都区三河街道互助社区二社;法定代表人为严玲;企业负责人为严玲;生产范围2017分类目II类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩川械注应急准20202140029.
","43908","43908","44091","四川省药品监督管理局""8","《医疗器械生产许可证》延续","四川沃文特生物技术有限公司","91510100577371682N","杨龙贤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150063号","同意延续.
住所为成都高新区西芯大道6号;生产地址为成都市高新区(西区)西芯大道6号3栋1层1号101室、102室、2层1号、2层2号、3层303号;法定代表人为杨龙贤;企业负责人为杨龙贤.
生产范围:2002年分类目录:Ⅱ类:6840--体外诊断试剂;2017分类目录:Ⅱ类:22-04-免疫分析设备,22-09-尿液及其他样本分析设备.
","43901","43901","45726","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","成都艾科斯伦医疗科技有限公司","915101226988525032","夏斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150051号","增加生产产品:1、D-二聚体(D-Dimer)检测试剂盒(胶乳免疫比浊法)(川械注准20202400031);2、抗凝血酶Ⅲ(ATⅢ)检测试剂盒(发色底物法)(川械注准20202400032);3、纤维蛋白(原)降解产物(FDP)检测试剂盒(胶乳免疫比浊法)(川械注准20202400033).
2002年分类目录:Ⅱ类:6840-1-血液分析系统,6840--体外诊断试剂,6864-2-敷料、护创材料","43909","43909","45691","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","四川空分医用设备工程股份有限公司","91512081206850713M","黄凯","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150065号","医用中心吸引系统的注册证号由川食药监械(准)字2013第2540151号变更为川械注准20182560110;医用分子筛变压吸附制氧机的注册证号由川食药监械(准)字2014第2540092号变更为川械注准20192080103;医用中心供氧系统的注册证号由川食药监械(准)字2014第2560038号变更为川械注准20182560110;减少2002分类目录:Ⅱ类6854-8-医用制气设备置;增加2017分类目录Ⅱ类Ⅱ类:08-04-医用制氧设备.
","43910","43910","44079","四川省药品监督管理局""11","《医疗器械生产许可证》法定代表人变更","成都天奥电子股份有限公司","9151010075598305X1","张建军","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190056号","法定代表人由徐建平变更为张建军;企业负责人由郑兴世变更为刘江.
","43910","43910","45601","四川省药品监督管理局""12","应急审批","四川双新制药有限公司","915101122709299919D","邹怀新","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200020号","新核发.
住所为成都双流西南航空港经济开发区空港二路361号;法定代表人为邹怀新;企业负责人为邹怀新;生产地址为成都双流西南航空港经济开发区空港二路361号1幢、8幢2楼;生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩川械注应急准20202140032.
","43910","43910","44093","四川省药品监督管理局""13","应急审批","宜宾丽雅新材料有限责任公司","91511500MA69NFPCXE","邓传东","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200021号","新核发.
法定代表人为邓传东;企业负责人为邓传东;住所为四川省宜宾叙州区莱茵河畔月光半岛商业独幢1幢1-3层;生产地址为四川省宜宾叙州区盐坪坝工业园区;2017年分类Ⅱ类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩川械注应急准20202140036;医用外科口罩川械注应急准20202140037.
","43910","43910","44093","四川省药品监督管理局""14","应急审批","四川安岚医疗科技有限公司","91511402MA664HFR8G","李彦英","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200022号","新核发.
法定代表人为李彦英;企业负责人为石洪波;住所为四川省眉山经济开发区新区(西部药谷);生产地址为四川省眉山经济开发区新区(西部药谷)鑫和工业园C6栋;2017年分类Ⅱ类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩川械注应急准20202140030;医用外科口罩川械注应急准20202140031.
","43910","43910","44093","四川省药品监督管理局""15","应急审批","四川普瑞斯生物科技有限公司","91511503563252148F","雷冰","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200023号","产品信息:一次性使用医用口罩川械注应急准20202140033;医用外科口罩川械注应急准20202140034.
","43910","43910","44093","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第6期)(截止2020.
4.
7)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","应急审批","佑华制药(乐山)有限公司","91511100MA6280126G","王志良","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200024号","新核发.
法定代表人为王志良;企业负责人为王志良;住所为四川省乐山高新区临江北路2号;生产地址为四川省乐山高新区临江北路2号;2017年分类Ⅱ类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩川械注应急准20202140035","43910","43910","44093","四川省药品监督管理局""2","应急审批","雅安市康乐医疗器械有限责任公司","91511800779815333J","肖勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200025号","新核发.
法定代表人为肖勇;企业负责人为何文革;住所为雅安市雨城区南郊乡狮子村;生产地址为雅安市雨城区南郊乡狮子村;2017年分类Ⅱ类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩,川械注应急准20202140038","43913","43913","44096","四川省药品监督管理局""3","应急审批","四川好医生攀西药业有限责任公司","91513401MA62H2JP38","耿福能","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200026号","新核发.
法定代表人为耿福能;企业负责人为文建国;住所为西昌市机场路;生产地址为凉山州西昌市机场路三段115号口罩生产车间;2017年分类Ⅱ类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩,川械注应急准20202140039.
","43913","43913","44096","四川省药品监督管理局""4","应急审批","四川太极医疗器械有限公司","91511325MA629EN468","梁豫川","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200027号","新核发.
法定代表人为梁豫川;企业负责人为梁豫川;住所为四川省南充市西充县多扶工业园区;生产地址为四川省南充市西充县多扶工业园区(双创中心一号楼);2017年分类Ⅱ类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩,川械注应急准20202140040.
","43913","43913","44096","四川省药品监督管理局""5","应急审批","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许2020004号","生产地址非文字性变更:由"成都市新津县新平镇万街村七组46号"变更为"成都市新津县新平镇万街村七组46号;成都市新津县金华镇宝峰东路260号102B生产车间".
","43914","43914","至国家宣布新型冠状病毒感染肺炎疫情解除","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","奥泰医疗系统有限责任公司","91510100771215018D","雷旸","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160024号","增加生产产品:乳腺磁共振成像系统(国械注准20203060138).
生产范围:2002分类目录:Ⅱ类:6823-1-超声诊断设备,6830-2-医用X射线诊断设备Ⅲ类:6828-1-医用磁共振成像设备(MRI)2017年分类目录:Ⅱ类:06-01-诊断X射线机,06-07-超声影像诊断设备Ⅲ类:06-09-磁共振成像设备(MRI)","43914","43914","44304","四川省药品监督管理局""7","《医疗器械生产许可证》生产地址非文字性变更","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","生产地址非文字性变更:由"成都市新津县新平镇万街村七组46号"变更为"成都市新津县新平镇万街村七组46号;成都市新津县金华镇宝峰东路260号102B生产车间".
住所为成都市新津县新平镇万街村七组46号;生产地址为成都市新津县新平镇万街村七组46号;成都市新津县金华镇宝峰东路260号102B生产车间.
","43914","43914","45614","四川省药品监督管理局""8","《医疗器械生产许可证》延续","中国核动力研究设计院设备制造厂","915111269075114823","罗绮","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150066号","同意延续.
住所为乐山市夹江县界牌镇;生产地址为乐山市夹江县界牌镇兴核二路1号;法定代表人为罗绮;企业负责人为许安建.
生产范围:2002分类目录:Ⅲ类:6830-2-医用X射线诊断设备,6832-2-高能射线治疗定位设备,6833-1-放射性核素治疗设备,6845-4-血液净化设备和血液净化器具2017年分类目录:Ⅲ类:05-01-放射治疗设备,05-02-放射治疗模拟及图像引导系统.
","43914","43914","45739","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","四川新健康成生物股份有限公司","9151010079780219XP","王大平","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170002号","增加生产产品:1、超敏肌钙蛋白I测定试剂盒(免疫荧光层析法)(川械注准:20192400227);2、肌钙蛋白I测定试剂盒(免疫荧光层析法)(川械注准:20192400228);3、β-人绒毛膜促性腺激素测定试剂盒(免疫荧光层析法)(川械注准:20192400229);4、糖化血红蛋白测定试剂盒(免疫荧光层析法)(川械注准:20192400230);5、N末端心房利钠肽前体测定试剂盒(免疫荧光层析法)(川械注准:20192400231);6、干式荧光免疫分析仪(川械注准:20192220223);干式荧光免疫分析仪(川械注准:20202220008).
生产范围:2002分类目录:Ⅱ类:6840-2-生化分析系统,6840--体外诊断试剂Ⅲ类:6840--体外诊断试剂2017年分类目录:Ⅱ类:22-02-生化分析设备.
","43914","43914","44573","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","声泰特(成都)科技有限公司","915101007712378908","RavinderSinghSethi","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150027号","减少生产产品:超声彩色多普勒诊断仪,川食药监械(准)字2014第2230145号.
","43915","43915","45575","四川省药品监督管理局""11","《医疗器械生产许可证》增加生产范围/增加生产产品","四川恒明科技开发有限公司","915101067559967907","廖佳明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180003号","特定电磁波谱治疗器的注册证号由川械注准20152260028变更为川械注准20152090028;热透TDP炎痛贴的注册证号由川械注准20152260038变更为川械注准20152090038;增加生产范围2017分类目录Ⅱ类:09-02-温热(冷)治疗设备/器具.
","43915","43915","44947","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","成都派瑞义齿科技发展有限公司","9151011478011987XH","徐寿祥","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150060号","延续注册后证号变更:定制式固定义齿的注册证号由川食药监械(准)字2012第2630171号变更为川械注准20162630197;定制式活动义齿的注册证号由川食药监械(准)字2012第2630170号变更为川械注准20162630196.
","43915","43915","44045","四川省药品监督管理局""13","应急核发","四川省巴中市向往科技开发有限公司","9151190072087446X6","喻川文","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200028号","新核发.
法定代表人为喻川文;企业负责人为喻川文;住所为四川省巴中市恩阳区恩阳镇工业园(二厂区)03号;生产地址四川省巴中市恩阳区恩阳镇工业园(二厂区)03号;2017年分类Ⅱ类:14-13-手术室感染控制用品;产品信息:一次性使用医用口罩川械注应急准20202140041.
","43915","43915","44098","四川省药品监督管理局""14","应急核发","泸州天诺科技有限公司","91510502MA65LJ6T4B","李向东","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200029号","新核发.
法定代表人为李向东;企业负责人为陶山春;住所为四川省泸州市江阳区创新路9号28栋;生产地址四川省泸州市江阳区创新路9号28栋;2017年分类目录:Ⅱ类:07-03-生理参数分析测量设备医用;产品信息:红外体温计川械注应急准20202070042.
","43915","43915","44098","四川省药品监督管理局""15","应急核发","成都神农堂实业有限公司","9151011573235500XL","刘迅","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200007号","应急核发.
住所为成都市温江区成都海峡两岸科技产业开发园西区永科路850号;生产地址为成都市温江区成都海峡两岸科技产业开发园海科路西段128号四川活态药业有限公司直服车间;法定代表人为刘迅;企业负责人为刘伟;生产范围2017分类目II类:14-13手术室感染控制用品;产品信息:医用外科口罩,川械注应急准20202140009.
","43878","43878","44059","四川省药品监督管理局""16","变更","四川丙寅医疗器械有限公司","91511402MA66WY30XB","刘圣君","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200014号","新增产品:医用一次性防护服川械注应急准20202140021.
","43892","43892","44075","四川省药品监督管理局""17","应急核发","遂宁摩天时代医疗器械有限公司","91510900MA66F2CJ2Y","吴升孟","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200030号","应急核发.
住所为四川省遂宁市经济技术开发区西宁片区纵一路3号楼2楼B区;生产地址为四川省遂宁市经济技术开发区西宁片区纵一路3号楼2楼B区;法定代表人为吴升孟;企业负责人为陈杰;生产范围2017分类目II类:14-13手术室感染控制用品;产品信息:一次性使用医用口罩,川械注应急准20202140043.
","43920","43920","44103","四川省药品监督管理局""18","应急核发","四川山岳生物科技有限公司","91512000MA666JH9XX","周文波","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200031号","应急核发.
住所为四川省资阳市现代大道3号A栋四层D、E、F区;生产地址为四川省资阳市现代大道3号A栋四层D、E、F区;法定代表人为周文波;企业负责人为周文波;生产范围2017分类目II类:14-13手术室感染控制用品;产品信息:医用外科口罩川械注应急准20202140044.
","43920","43920","44103","四川省药品监督管理局""19","《医疗器械生产许可证》增加生产范围/增加生产产品","成都爱兴生物科技有限公司","915101000643341495","包德泉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190001号","增加生产产品:血清淀粉样蛋白A测定试剂盒,川械注准20202400017.
","43901","43901","45298","四川省药品监督管理局""20","《医疗器械生产许可证》延续","成都市新兴内窥镜科技有限公司","915101082022156674","王传林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150043号","同意延续.
住所为成都市双林路388号富临大厦17楼A座;生产地址为成都市新都区新都街道自强路66号;法定代表人为王传林;企业负责人为王传林.
生产范围:2002分类目录:Ⅱ类:6854-11-诊察治疗设备2017年分类目录:Ⅱ类:06-14-医用内窥镜,06-15-内窥镜功能供给装置Ⅲ类:06-14-医用内窥镜.
","43901","43901","45726","四川省药品监督管理局""21","《医疗器械生产许可证》核发","成都利尼科医学技术发展有限公司","91510115669664933Q","王健","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200013号","新核发.
住所为成都市温江区成都海峡两岸科技产业开发园学府路;生产地址为成都温江区成都海峡两岸科技产业开发园学府路;法定代表人为王健;企业负责人为杨光.
生产范围为2002分类目录:Ⅲ类:6832-1-医用高能射线治疗设备.
","43901","43901","45726","四川省药品监督管理局""22","《医疗器械生产许可证》延续","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150057号","同意延续.
住所为天府新区仁寿视高经济开发区兴园路;生产地址为天府新区仁寿视高经济开发区兴园路;法定代表人为陆盘兴;企业负责人为陆盘中.
生产范围:2002分类目录:Ⅱ类:6808-6-一次性使用直线型切割缝合器,6808-6-一次性使用直线缝合器,6866-5-呼吸麻醉或通气用气管插管;2017年分类目录:Ⅱ类:02-13-手术器械-吻(缝)合器械及材料,08-06-呼吸、麻醉用管路、面罩,14-02-血管内输液器械,17-05-口腔充填修复材料,22-11-采样设备和器具Ⅲ类:10-02-血液分离、处理、贮存器具,14-01-注射、穿刺器械,14-02-血管内输液器械,22-11-采样设备和器具.
","43901","43901","45726","四川省药品监督管理局""23","《医疗器械生产许可证》增加生产范围/增加生产产品","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150057号","增加生产产品:一次性使用包皮切割吻合器川械注准20202020006","43921","43921","45726","四川省药品监督管理局""24","《医疗器械生产许可证》增加生产范围/增加生产产品","绵阳立德电子股份有限公司","91510700717509138R","文云洋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150003号","增加生产产品/生产范围:手术电极的注册证号由川械注准20152250050变更为川械注准20152010050,增加一次性使用射频消融电极针,国械注准20203010137,增加2017年分类目录:Ⅱ类:01-03-高频/射频手术设备及.
","43921","43921","45503","四川省药品监督管理局""25","《医疗器械生产许可证》延续","成都派瑞义齿科技发展有限公司","9151011478011987XH","徐寿祥","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150060号","同意延续注册.
住所为成都市新都区工业东区白云路789号综合楼三楼;生产地址为成都市新都区工业东区白云路789号综合楼三楼;法定代表人为徐寿祥;企业负责人为侯聃.
生产范围:2002分类目录Ⅱ类:6863-16-定制式义齿.
","43921","43921","45746","四川省药品监督管理局""26","《医疗器械生产许可证》增加生产范围/增加生产产品","四川锦江电子科技有限公司","915101077348059327","李楚文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150016号","增加生产产品:体表参考电极,川械注准20202070035;增加生产范围(2017年分类)Ⅱ类:07-10-、耗材;","43923","43923","45484","四川省药品监督管理局""27","《医疗器械生产许可证》增加生产范围/增加生产产品","成都顺雅医疗用品有限公司","9151012275283864X6","向守香","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180037号","生产地址非文字性变更由1、成都市双流区东升镇龙桥路6号宗申赛纳维129栋1单元2楼201号、202号,3楼301号、302号.
2、成都市西航港经济开发区空港四路2666号10区202号.
变更为成都市西航港经济开发区空港四路2666号10区202号","43923","43923","45208","四川省药品监督管理局""28","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","增加生产产品:一次性使用输液延长管,国械注准20203140189;一次性使用精密过滤输液器,国械注准20203140163;一次性使用输液器,国械注准20203140164;一次性使用袋式输液器,国械注准20203140165;一次性使用精密过滤袋式输液器,国械注准20203140166;增加2017年分类目录:20-02-中医治疗设备.
","43923","43923","45614","四川省药品监督管理局""29","《医疗器械生产许可证》增加生产范围/增加生产产品","眉山安凯义齿有限公司","91511402080749678U","彭淼","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150068号","延续注册后证号变更:定制式活动义齿的注册证号由川食药监械(准)字2014第2630082号变更为川械注准20192170104.
","43923","43923","44111","四川省药品监督管理局""30","《医疗器械生产许可证》核发","四川金诺义齿技术服务有限公司","91511302MA682QE576","庞富成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200016号","新核发.
住所为南充市顺庆区潆华工业区BD-C地块;生产地址为南充市顺庆区潆华工业园区华荣路二段168号南充恩佩瑞机电有限公司厂区内6幢3楼;法定代表人为庞富成;企业负责人为庞富成.
生产范围为2002分类目录:Ⅱ类:6863-16-定制式义齿;2017年分类分类目录:Ⅱ类:17-06-口腔义齿制作材料.
","43921","43921","45746","四川省药品监督管理局""31","《医疗器械生产许可证》核发","成都乐享智家科技有限责任公司","915101003215356207","王刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200015号","新核发.
住所为中国(四川)自由贸易试验区成都高新区天府大道北段1480号1栋A座2层5附5号;生产地址为成都崇州经济开发区世纪大道1343号B区1号办公楼第四层;法定代表人为王刚;企业负责人为邓韩彬.
生产范围为2002分类目录:Ⅱ类:6821-13-电子压力测定装置;2017年分类分类目录:Ⅲ类:07-04-监护设备.
","43921","43921","45746","四川省药品监督管理局""32","《医疗器械生产许可证》核发","成都数浪信息科技有限公司","91510100MA6C70B588","张子骄","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200014号","新核发.
住所为四川省成都市天府新区华阳街道长江东二街56号1栋1层1室;生产地址为四川成都市高新区吉泰五路88号3栋5层507室;法定代表人为张子骄;企业负责人为杨紫陌.
生产范围为2002分类目录:Ⅱ类:6870-4-影象档案传输、处理系统软件;2017年分类分类目录:Ⅱ类:21-02-影像处理软件.
","43921","43921","45746","四川省药品监督管理局""33","应急核发","四川超迪电器实业有限公司","915120227175188434","吴国金","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200032号","应急核发.
住所为乐至县天池镇东郊路2号;生产地址为四川省资阳市乐至县集中工业发展区超迪大道4号1栋A区;法定代表人为吴国金;企业负责人为陈昔强;生产范围2017年分类目录:Ⅱ类:07-03-生理参数分析测量设备;产品信息:医用红外体温计川械注应急准20202070046.
","43923","43923","44105","四川省药品监督管理局""34","应急核发","成都老鹰信息技术有限公司","91510100MA61UB1J4E","杨解清","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200035号","应急核发.
住所为成都市温江区成都海峡两岸科技产业开发园锦绣大道南段281号(智立方)3-302;生产地址为成都市温江区成都海峡两岸科技产业开发园锦绣大道南段281号(智立方)3-302、3-102;法定代表人为杨解清;企业负责人为杨解清;生产范围2017年分类目录:Ⅱ类:07-03-生理参数分析测量设备;产品信息:医用红外体温计,川械注应急准20202070045.
","43923","43923","44105","四川省药品监督管理局""35","《医疗器械生产许可证》增加生产范围/增加生产产品","成都美创医疗科技股份有限公司","91510100743628755X","李安民","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150031号","延续注册后证号变更:1、高频手术治疗仪延续注册后,注册证号由"川械注准20152250021"变更为"川械注准20152010021";2、等离子体手术系统延续注册后,注册证号由"国械注准20143252238"变更为"国械注准20143012238";3、一次性射频等离子体手术电极延续注册后,注册证号由"川械注准20152250027"变更为"川械注准20152010027".
","43924","43924","45576","四川省药品监督管理局""36","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:糖化血红蛋白测定试剂盒(高效液相色谱法),川械注准20202400025.
","43924","43924","45687","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第7期)(截止2020.
4.
10)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》延续","四川大学生物材料工程研究中心","91510100201990565A","张兴栋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150049号","同意延续.
住所为成都市望江路29号;生产地址为成都市望江路29号;成都高新区西芯大道26号1栋及生产科研综合楼1楼;法定代表人为张兴栋,企业负责人为王云兵;生产范围(2002年分类)2002年分类目录:Ⅲ类:6846-1-植入器材,6863-2-齿科植入材料,6863-3-根管充填材料.
2017年分类目录:Ⅲ类:13-05-骨科填充和修复材料,17-08-口腔植入及组织重建材料.
","43928","43928","45753","四川省药品监督管理局""2","《医疗器械生产许可证》延续","四川射洪通用医疗器械有限公司","91510922662760199U","马林荣","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150059号","同意延续.
法定代表人为马林荣,企业负责人为马林荣;住所为射洪县太和镇顺美大道美丰工业城机电园;生产地址为射洪县太和镇顺美大道美丰工业城机电园;生产范围为2002分类目录Ⅱ类:6857-2-压力蒸汽灭菌设备.
","43928","43928","45753","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","老肯医疗科技股份有限公司","915101007130698769","刘霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149006号","增加生产产品:内镜清洗工作站,川械注准20202110037","43928","43928","45595","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都青山利康药业有限公司","91510100732384126D","刘革新","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150004号","增加生产产品:一次性使用无菌药液转移器,川械注准20202140036;增加生产范围(2017年分类)Ⅱ类:14-02-血管内输液器械","43928","43928","45539","四川省药品监督管理局""5","《医疗器械生产许可证》生产地址非文字性变更","成都市牙立方义齿技术有限公司","91510122331958520Y","龚发佳","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160009号","住所由中国(四川)自由贸易试验区成都市双流区西航港开发区黄甲街道黄甲镇杨桥路666号4楼5楼变更为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区龙湖路48号;生产地址非文字性变更由中国(四川)自由贸易试验区成都市双流区西航港开发区黄甲街道黄甲镇杨桥路666号4楼5楼变更为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区龙湖路48号1栋2层","43929","43929","44214","四川省药品监督管理局""6","《医疗器械生产许可证》企业负责人变更","成都美创医疗科技股份有限公司","91510100743628755X","李安民","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150031号","企业负责人由邓春雷变更为崔腾.
","43929","43929","45576","四川省药品监督管理局""7","《医疗器械生产许可证》延续","四川空分医用设备工程股份有限公司","91512081206850713M","黄凯","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150065号","同意延续.
住所为简阳市工业园区凯力威工业大道北段;生产地址为简阳市工业园区凯力威工业大道北段;法定代表人为黄凯;企业负责人为黄凯.
生产范围:2002分类目录Ⅱ类:6854-6-负压吸引装置,6856-1-供氧系统2017分类目录Ⅱ类:08-04-医用制氧设备","43930","43930","45755","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","成都口口齿科技术有限公司","川食药监械生产许20170019号","陈闻多","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170019号","增加生产产品:定制式矫治器,川械注准20202170028;定制式保持器,川械注准20202170029,增加2017年分类目录:Ⅱ类:17-06-口腔义齿制作材料,17-07-口腔正畸材料及制品","43930","43930","44718","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","成都欧赛医疗器械有限公司","91510122768647821B","甘释良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150011号","一次性使用透析护理包延续注册,注册证号由川械注准20152640046变更为川械注准20152140046;减少2002分类目录Ⅱ类:6864-2-敷料、护创材料,增加2017年分类目录Ⅱ类:14-09-不可吸收外科敷料.
","43930","43930","45516","四川省药品监督管理局""10","《医疗器械生产许可证》延续","四川省广元市康康医疗器械有限公司","915108007298019616","陈晓英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150072号","同意延续.
法定代表人为陈晓英;企业负责人为陈晓英;住所为广元市朝天区七盘关工业园区;生产地址为广元市朝天区中子镇中曾路10号;生产范围为2002分类目录Ⅲ类:6866-1-输液、输血器具及管路2017分类目录Ⅲ类:06-05-X射线附属及辅助设备.
","43931","43931","45756","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第8期)(截止2020.
4.
17)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》法定代表人变更","四川优可得医疗器械有限公司","91510700MA6BBMHQ94","何志龙","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200006号","法定代表人由陈华英变更为何志龙","43934","43934","45686","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","绵阳美科电子设备有限责任公司","91510700MA6242UH7Q","赵文军","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150018号","增加生产产品膀胱扫描仪,川械注准20202060039;增加2017年分类目录:Ⅱ类:06-07-超声影像诊断设备.
","43934","43934","45576","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省智能电子实业有限公司","91510100202076847A","吴洪宇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150073号","数字化脑电监护分析仪延续注册由川械注准20142210039变更为川械注准20142070039;智能电刺激仪延续注册,产品名称变更为直流脉冲电刺激仪,注册证号由川械注准20142210040变更为川械注准20142090040;增加生产范围2017年分类目录:Ⅱ类:07-03-生理参数分析测量设备,09-01-电疗设备/器具.
","43934","43934","44185","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","中青康源成都医疗技术有限公司","91510100MA62MYKP47","蒲丹","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190024号","增加生产产品超声肝检测仪,川械注准20202060034.
","43936","43936","45454","四川省药品监督管理局""5","《医疗器械生产许可证》生产地址非文字性变更","成都美益达医疗科技有限公司","915101000600892974","张晓金","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150045号","生产地址非文字性变更由成都高新区天映路102号(主楼)四楼变更为成都高新区天映路102号(主楼)四楼、五楼;产品延续注册后证号变更,医用消毒超声耦合剂川械注准20152230044变更为川械注准20152060044;减少生产范围(2002年分类)范围(2002年分类)Ⅱ类:6823-4-其他;增加生产范围(2017年分类)Ⅱ类:06-08-超声影像诊断附属设备.
","43936","43936","45697","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","成都维信电子科大新技术有限公司","9151010062171126X9","陈志强","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149002号","气体压缩式雾化器的注册证号码由川械注准20152210178变更为川械注准20152080178;增加生产产品:一次性使用输尿管引流管,川械注准20202140038.
","43936","43936","45442","四川省药品监督管理局""7","《医疗器械生产许可证》法定代表人变更","四川鸿政博恩口腔科技有限公司","91512000MA675NEL5M","石雅成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200005号","企业负责人由王立新变更为石雅成","43936","43936","45675","四川省药品监督管理局""8","《医疗器械生产许可证》法定代表人变更","四川博美星口腔设备有限公司","91512000MA65890F3Y","陈悟","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药械生产许20180034号","企业负责人由陈华志变更为陈悟法定代表人由陈华志变更为陈悟","43936","43936","45197","四川省药品监督管理局""9","《医疗器械生产许可证》企业名称变更","四川拜阿蒙生物活性材料有限责任公司","91510100201990565A","朱向东","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150049号","企业名称由四川大学生物材料工程研究中心变更为四川拜阿蒙生物活性材料有限责任公司;法定代表人由张兴栋变更为朱向东;企业负责人由王云兵变更为朱向东","43937","43937","45753","四川省药品监督管理局""10","《医疗器械生产许可证》延续","绵阳市先锋医疗器械有限公司","9151070078226515X6","许先锋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150056号","同意延续.
法定代表人为许先锋;企业负责人为许先锋;住所为绵阳高新区飞云大道东段261号出口加工区406厂房第四层;生产地址为绵阳高新区飞云大道东段261号出口加工区406厂房第四层;生产范围为2002分类目录Ⅱ类:6823-1-超声诊断设备2017分类目录Ⅱ类:06-07-超声影像诊断设备.
","43937","43937","45762","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第9期)(截止2020.
4.
24)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川新健康成生物股份有限公司","9151010079780219XP","王大平","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170002号","增加生产产品:D-二聚体测定试剂盒(免疫荧光层析法),川械注准20202400048;C反应蛋白/血清淀粉样蛋白A联卡测定试剂盒(免疫荧光层析法),川械注准20202400047;复合免疫校准品,川械注准20202400046.
","43945","43945","44573","四川省药品监督管理局""2","《医疗器械生产许可证》延续","成都超吉科技有限公司","91510107752819748U","敬锡志","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150070号","同意延续.
住所为成都市武侯区武青南路33号;生产地址为成都市高新区新文路22号8栋1层3号1楼、负1楼;法定代表人为敬锡志;企业负责人为敬锡志;生产范围(2002年分类)为Ⅱ类:6864-2-敷料、护创材料.
","43945","43945","45770","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都昌华科技有限责任公司","91510100792152378M","陈昌标","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150010号","增加生产产品一次性使用无菌气管插管,川械注准20162660235;呼吸道用吸引导管,川械注准20162660236;一次性使用热湿交换器,川械注准20202080043;一次性使用无菌硅胶气管插管,川械注准20202080044;一次性使用无菌气雾式给药器,川械注准20202140045.
增加生产范围(2017年分类)Ⅱ类:08-05-呼吸、麻醉、急救设备辅助装置.
","43945","43945","45454","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","四川恒和鑫口腔科技有限公司","91512000MA64J16Y4L","王杰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180010号","减少生产产品定制式固定义齿,川械注准20172630234,受托生产2020年3月22日;定制式活动义齿,川械注准20172630233,受托生产2020年3月22日;增加生产产品定制式固定义齿,川械注准20172630234,受托生产,2021年3月31日;定制式活动义齿,川械注准20172630233,受托生产,2021年3月31日.
","43945","43945","44979","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第10期)(截止2020.
4.
30)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》企业负责人变更","四川航天世都制导有限公司","91510112202245436J","许增华","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160052号","企业负责人由张金亚变更为许增华.
","43947","43947","44445","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","老肯医疗科技股份有限公司","915101007130698769","刘霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149006号","医用全自动清洗消毒机的注册证号由川械注准20152570163变更为川械注准20152110163","43948","43948","45595","四川省药品监督管理局""3","《医疗器械生产许可证》延续","成都维登义齿科技有限公司","9151010755643869XC","李光林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150052号","同意延续.
住所为成都市武侯区武青西四路3号1栋4层3号、5层;生产地址为成都市武侯区武青西四路3号1栋5层;法定代表人为李光林;企业负责人为李光林;生产范围(2002年分类)Ⅱ类:6863-16-定制式义齿.
","43948","43948","45773","四川省药品监督管理局""4","《医疗器械生产许可证》核发","四川希氏异构医疗科技有限公司","91510115MA6CM6T691","宋捷","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200017号","法定代表人为宋捷;企业负责人为宋捷;住所为成都市温江区永宁镇八一路北段18号1栋3单元4层401号;生产地址为成都市温江区永宁镇八一路北段18号1栋3单元4层401号;生产范围为2002分类目录Ⅱ类:6870-4-影象档案传输、处理系统软件2017分类目录Ⅱ类:06-18-图像显示、处理、传输及打印设备;产品名称:消化内镜影像实时辅助诊断设备川械注准20202060049.
","43948","43948","45773","四川省药品监督管理局""5","《医疗器械生产许可证》延续","慨迩医疗科技(成都)有限公司","91510100201954513W","EarlDavidLawson","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150069号","同意延续.
住所为四川省成都市郫都区成都现代工业港南片区清马路48号;生产地址为四川省成都市郫都区成都现代工业港南片区清马路48号D车间、E车间;法定代表人为EarlDavidLawson;企业负责人为景山;生产范围2002分类目录:Ⅱ类:6854-8-医用制气设备2017分类目录:Ⅱ类:08-04-医用制氧设备.
","43948","43948","45773","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","四川正美齿科科技有限公司","91512000MA691N2079","姚峻峰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190009号","增加生产产品定制式隐形正畸矫治器,浙械注准20192170581,受托生产截止2023年8月15日.
","43948","43948","45312","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","成都艾科斯伦医疗科技有限公司","915101226988525032","夏斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150051号","减少生产产品:阴道填塞,川械注准20152640188;产品延续注册后证号变更:全自动凝血分析仪的注册证号由川械注准20152400052变更为川械注准20152220052;减少2002分类目录Ⅱ类:6840-1-血液分析系统,6864-2-敷料、护创材料;增加2017分类目录Ⅱ类:22-01-血液学分析设备.
","43951","43951","45691","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","成都普什医药塑料包装有限公司","91510100785423440P","袁文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150046号","增加生产产品:一次性使用医用口罩,川械注准20202140053;增加生产范围2017分类目录:Ⅱ类:14-13-手术室感染控制用品;生产地址文字性变更由成都高新西区科新路6号变更为成都高新西区科新路6号1栋A座3楼、2栋、4栋.
","43951","43951","45652","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第11期)(截止2020.
5.
9)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》延续","眉山安凯义齿有限公司","91511402080749678U","彭淼","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150068号","同意延续.
住所为眉山市东坡区尚义镇红岗村圣丰农产品物流批发市场一期B区17栋3楼2号;生产地址为眉山市东坡区尚义镇红岗村圣丰农产品物流批发市场一期B区17栋3楼2号;法定代表人为彭淼;企业负责人为张莺;产品范围2002分类目录:Ⅱ类:6863-16-定制式义齿2017分类目录:Ⅱ类:17-06-口腔义齿制作材料.
","43951","43951","45776","四川省药品监督管理局""2","《医疗器械生产许可证》延续","攀枝花市川美义齿制作有限公司","915104020644598655","樊正萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150053号","同意延续.
住所为攀枝花市仁和区仁和镇仁和新村商业街西6号楼(正商街48号)三楼;生产地址为攀枝花市仁和区仁和镇仁和新村商业街西6号楼(正商街48号)3楼301;法定代表人为樊正萍;企业负责人为岳兵;产品范围:2002分类目录Ⅱ类:6863-16-定制式义齿","43957","43957","45782","四川省药品监督管理局""3","《医疗器械生产许可证》核发","四川美鸣医疗器械有限公司","91510108395458859Y","李志","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200018号","新核发.
法定代表人为李志;企业负责人为李志;住所为成都市成华区龙潭工业园成佳路16号2号研发楼第五层;生产地址为成都市成华区龙潭工业园成佳路16号2号研发楼第五层;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿;产品信息:1定制式固定义齿川械注准20162630061;2定制式活动义齿川械注准20162630062.
","43957","43957","45782","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都顺雅医疗用品有限公司","9151012275283864X6","向守香","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180037号","增加生产产品:定制式保持器,川械注准20202170052.
","43957","43957","45208","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都创宜生物科技有限公司","915101005510619933","向阳","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150034号","妊娠期补体因子D子痫前期快速测定试剂盒(胶体金法)的产品名称变更为补体因子D检测试剂盒(胶体金法)","43959","43959","45576","四川省药品监督管理局""6","《医疗器械生产许可证》企业负责人变更","成都登特牙科技术开发有限公司","91510122743620809W","蒋安琪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150014号","企业负责人由朱刚变更为李毅","43959","43959","45650","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第12期)(截止2020.
5.
15)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》生产地址非文字性变更","南充市顺庆区艺美义齿加工中心","91511302MA6290H824","曾建君","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160023号","住所由南充市顺庆区潆溪镇潆康南路291号(C区2号楼2楼)变更为南充市顺庆区潆华工业园BD—C地块(华荣路二段168号6幢2楼1号);生产地址非文字性变更由南充市顺庆区潆溪镇潆康南路291号(C区2号楼2楼)变更为南充市顺庆区潆华工业园BD—C地块(华荣路二段168号6幢2楼1号).
","43962","43962","44304","四川省药品监督管理局""2","《医疗器械生产许可证》企业负责人变更","攀枝花市川美义齿制作有限公司","915104020644598655","樊正萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150053号","企业负责人由岳兵变更为樊正萍","43962","43962","45782","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第13期)(截止2020.
6.
1)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","成都维登义齿科技有限公司","9151010755643869XC","李光林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150052号","定制式固定义齿的注册证号由川械注准20152630048变更为川械注准20152170048;定制式活动义齿的注册证号由川械注准20152630049变更为川械注准20152170049;增加生产范围2017分类目录:Ⅱ类:17-06-口腔义齿制作材料.
","43969","43969","45773","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都试金石软件开发有限责任公司","915101057323842144","杨梨","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170039号","影像存贮和传输系统(PACS)软件延续注册后产品名称变更为影像存贮和传输系统软件,注册证号由川食药监械(准)字2014第2700097号变更为川械注准20192210159;增加生产范围2017分类目录:Ⅱ类:21-02-影像处理软件.
","43969","43969","44874","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都联帮医疗科技股份有限公司","91510100633135511R","谢邦庆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150007号","增加医用气体报警系统,川械注准20202080026;医用中心吸引系统的注册证号由川械注准20162560021变更为川械注准20162140021;增加生产范围2017分类目录:Ⅱ类:14-06-与非血管内导管配套用体外器械.
","43969","43969","45448","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都科宁达材料有限公司","915101077686235204","李宁","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160008号","延续注册后变更,牙科烤瓷镍铬合金的注册证号由川食药监械(准)字2014第2630078变更为川械注准20192170094;牙科烤瓷钴铬生物合金的产品名称变更为牙科烤瓷钴铬合金,注册证号由川食药监械(准)字2014第2630079变更为川械注准20192170093;牙科钴铬支架合金的注册证号由川食药监械(准)字2014第2630080变更为川械注准20192170092;增加2017分类目录:Ⅱ类:17-06-口腔义齿制作材料.
","43969","43969","44214","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","产品延续注册后变更:巨细胞病毒IgM抗体质控物(化学发光法)延续注册后注册证号未变,产品名称变更为巨细胞病毒IgM抗体质控品(化学发光法);弓形虫IgG抗体质控物(化学发光法)延续注册后注册证号未变,产品名称变更为弓形虫IgG抗体质控品(化学发光法);风疹病毒IgM抗体质控物(化学发光法)延续注册后注册证号未变,产品名称变更为风疹病毒IgM抗体质控品(化学发光法);增加产品为新型冠状病毒(2019-nCoV)IgG抗体检测试剂盒(直接化学发光法),国械注准20203400496;新型冠状病毒(2019-nCoV)IgM抗体检测试剂盒(直接化学发光法)国械注准20203400497.
","43970","43970","45687","四川省药品监督管理局""6","《医疗器械生产许可证》延续","四川三和医用材料有限公司","91510121746435609C","梁毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150061号","同意延续.
住所为成都市金堂县赵镇金广路;生产地址为成都市金堂县赵镇金广路;法定代表人为梁毅;企业负责人为梁旭;产品范围2002分类目录:Ⅱ类:6864-2-敷料、护创材料料.
","43973","43973","45798","四川省药品监督管理局""7","《医疗器械生产许可证》企业住所变更","成都普什医药塑料包装有限公司","91510100785423440P","俞文骥","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150046号","住所由"成都高新区西部园区"变更为"成都高新区(西区)科新路6号1栋、2栋".
","43976","43976","45652","四川省药品监督管理局""8","《医疗器械生产许可证》核发","成都桦恩医疗器械有限责任公司","91510121MA6DG9K68D","刁玉兰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200019号","新核发.
法定代表人为刁玉兰;企业负责人为刁玉兰;住所为四川省成都市金堂县赵镇迎宾大道一段8号1栋2单元19层1号;生产地址为成四川省成都市金堂县淮口镇成都-阿坝工业集中发展区金乐路65号2号厂房;生产范围为2002分类目录:Ⅲ类:6810-8-6810-8矫形(骨科)外科用其他器械,6846-1-植入器材;2017年分类分类目录:Ⅱ类:04-17-脊柱外科辅助器械Ⅲ类:13-01-骨接合植入物.
产品信息:1、带锁髓内钉(国械注准20193131019);2、椎体成形工具包(川械注准20202040050);3、锁定型金属接骨螺钉(国械注准20203130411);4、金属接骨螺钉(非锁定)(国械注准20203130427).
","43979","43979","45804","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","成都爱兴生物科技有限公司","915101000643341495","包德泉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190001号","增加生产产品:1、炎症复合质控品(川械注准20202400056);2、心肌复合质控品(川械注准20202400055).
","43979","43979","45298","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","四川阿尔泰医疗器械有限公司","91510681665385216T","黄永兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160025号","增加生产产品:金属髓内针(国械注准20203130214).
","43979","43979","44307","四川省药品监督管理局""11","《医疗器械生产许可证》企业负责人变更","四川瑞珏医疗器械有限公司","91512000MA666LW58M","魏霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180040号","企业负责人由母春林变更为魏霞","43980","43980","45222","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第14期)(截止2020.
6.
15)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》法定代表人变更","四川瑞迪医疗科技有限公司","91510100777454861C","黄晓波","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170034号","法定代表人由陈小坤变更为黄晓波;企业负责人由陈小坤变更为黄晓波.
","43985","43985","44824","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","四川绵竹鸿基制药有限责任公司","91510683738346526R","廖达成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190047号","增加生产产品:1、炎一次性使用离心式血浆分离器(国械注准20203100350);2、血浆采集机(国械注准20203100439).
","43985","43985","45560","四川省药品监督管理局""3","《医疗器械生产许可证》生产地址非文字性变更","成都美创医疗科技股份有限公司","91510100743628755X","李安民","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150031号","生产地址非文字性变更:由"成都市温江区成都海峡两岸科技产业开发园科林路西段618号华银工业港9区11号成都市温江区天府科林路西段618号20栋1层1号201"变更为"成都市温江区成都海峡两岸科技产业开发园科林路西段618号华银工业港9区11号成都市温江区天府科林路西段618号20栋1层1号201成都市温江区天府科林路西段618号9栋3号".
","43985","43985","45576","四川省药品监督管理局""4","《医疗器械生产许可证》法定代表人变更","成都华神生物技术有限责任公司","915101007801171102","陈英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150013号","法定代表人由张文武变更为陈英.
","43991","43991","45503","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都齿研科技有限公司","9151012275877187XK","易敏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180021号","产品延续注册后注册证号变更.
定制式固定义齿的注册证号由川械注准20152630071变更为川械注准20152170071;定制式活动义齿的注册证号由川械注准20152630072变更为川械注准20152630072.
生产范围由2002分类目录:Ⅱ类:6863-16-定制式义齿变更为2017分类目录:Ⅱ类:17-06-口腔义齿制作材料.
","43991","43991","45082","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","四川微迪数字技术有限公司","91510100716092123A","钟茂","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160028号","产品延续注册后注册证号变更.
耳鸣综合诊断治疗仪的注册证号由川械注准20152210025变更为川械注准20152070025.
生产范围由2002分类目录:Ⅱ类:6821-8-电声诊断仪器,6846-5-器官辅助装置,6855-1-口腔综合治疗设备变更为类目录:Ⅱ类:07-05-电声学测量、分析设备.
","43991","43991","44335","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新兴内窥镜科技有限公司","915101082022156674","王传林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150043号","产品延续注册后注册证号变更.
医用手术冲吸切割器,注册证号由川械注准20152540026变更为川械注准20152010026;腹腔镜手术器械,注册证号由川食药监械(准)字2014第2220152号变更为川械注准川械注准20202020054.
增加生产范围2017分类目录:Ⅱ类:01-10-其他手术设备,02-04-手术器械-钳.
","43997","43997","45726","四川省药品监督管理局""8","《医疗器械生产许可证》核发","儒蓉(成都)医疗科技有限公司","91510100MA6CE4W85M","CHANQIANWANG","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200021号","新核发.
法定代表人为CHANQIANWANG;企业负责人为HAOZHOU;住所为中国(四川)自由贸易试验区成都高新区天府大道北段1480号1栋A-4-35号;生产地址为中国(四川)自由贸易试验区成都高新区天府大道北段1480号1栋A-4-35号;生产范围为2002分类目录:Ⅱ类:6863-16-定制式义齿;2017年分类分类目录:Ⅱ类:17-06-口腔义齿制作材料.
产品信息:定制式固定义齿(川械注准20202170062).
","43997","43997","45791","四川省药品监督管理局""9","《医疗器械生产许可证》核发","资阳频泰医疗设备有限公司","91512000MA64Y2CA0R","敖明武","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200020号","新核发.
法定代表人为敖明武;企业负责人为敖明武;住所为四川省资阳市现代大道3号A栋四层A、B、C区;生产地址为四川省资阳市现代大道3号A栋四层A、B、C区;生产范围为2002分类目录:Ⅱ类:6855-1-口腔综合治疗设备;2017年分类分类目录:Ⅱ类:17-01-口腔诊察设备.
产品信息:口腔数字印模仪(川械注准20202170059).
","43997","43997","45791","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:生长激素测定试剂盒(直接化学发光法),注册号川械注准20202400058;延续注册产品:单纯疱疹病毒1/2型IgM抗体质控品(化学发光法),注册证号国械注准20153400441.
","43997","43997","45687","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第15期)(截止2020.
6.
22)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》生产地址文字性变更","四川港通医疗设备集团股份有限公司","91510100206881448P","陈永","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149014号","住所由"四川省成都市简阳市凯力威工业大道南段11号"变更为"四川省成都市简阳市凯力威工业大道南段356号";生产地址文字性变更由"四川省成都市简阳市凯力威工业大道南段11号四川省成都市简阳市凯力威工业大道南段11号"变更为"四川省成都市简阳市凯力威工业大道南段356号".
","43998","43998","45474","四川省药品监督管理局""2","《医疗器械生产许可证》延续","腾博义齿制造成都有限公司","91510112331961391K","李征宇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160006号","同意延续.
住所为四川省成都经济技术开发区(龙泉驿区)南一路999号1栋4层1号;生产地址为四川省成都经济技术开发区(龙泉驿区)南一路999号1栋4层1号;法定代表人为李征宇;企业负责人为李征宇;产品范围2002分类目录:Ⅱ类:6863-16-定制式义齿.
","43999","43999","45824","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川博凯医疗电子有限责任公司","915120216602792031","马聪晓","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160003号","1、减少生产产品;医用诊断X射线机,注册证号"川食药监械(准)字2014第2300043号";2、医用诊断X射线机延续注册后,注册证号由"川食药监械(准)字2013第2300046号"变更为"川械注准20182300022".
","43999","43999","44209","四川省药品监督管理局""4","《医疗器械生产许可证》企业名称/住所变更","成都信汇聚源科技有限公司","915101003994210338","刘毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180014号","住所由"成都高新区吉泰五路88号3栋43楼3号"变更为"中国(四川)自由贸易试验区成都高新区天华二路219号12栋5层501号".
","43999","43999","44999","四川省药品监督管理局""5","《医疗器械生产许可证》企业负责人变更","四川海汇药业有限公司","91510122062401950W","徐镜人","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190058号","企业负责人由"施猛"变更为"宣伟".
","44000","44000","45601","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","成都新炬化工有限公司","91510114202593094Q","夏雪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160007号","产品延续注册后注册证号变更.
医用中心供氧系统延续注册后,注册号由"川械注准20152560081"变更为"川械注准20152080081";医用中心吸引系统延续注册后,注册证号由"川械注准20152540082"变更为"川械注准20152140082",生产范围由"2002分类目录:Ⅱ类:6854-6-负压吸引装置,6856-1-供氧系统"变更为"2017分类目录:Ⅱ类:08-07-医用供气排气相关设备,14-06-与非血管内导管配套用体外器械"","44001","44001","44214","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省菲娅医疗器械有限公司","91512000MA67838U2F","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190061号","增加生产产品:不锈钢正畸丝,注册证号"川械注准20202170060"","44001","44001","45617","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","四川山岳生物科技有限公司","91512000MA666JH9XX","周文波","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190037号","增加生产产品:磷酸酸蚀剂,注册证号"川械注准20202170014".
","44001","44001","45503","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","四川明峰医疗科技有限公司","91510131MA6C8YK61E","潘华素","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190038号","增加生产产品:X射线计算机体层摄影设备,注册证号"国械注准20203060527".
","44001","44001","45503","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","成都博奥晶芯生物科技有限公司","91510115577375018L","宋云鹏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150041号","增加生产产品:基因测序仪,注册证号"国械注准20203220502".
","44001","44001","45601","四川省药品监督管理局""11","《医疗器械生产许可证》核发","成都爱睿康乐医疗器械有限公司","91510122MA61X0YU0U","李财辉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200022号","新核发.
法定代表人为李财辉;企业负责人为李建树;住所为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区黄甲街道双兴大道83号8栋3楼附1号;生产地址为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区黄甲街道双兴大道83号8栋3楼附1号;生产范围为2002分类目录:Ⅱ类:6863-8-齿科预防保健材料.
2017年分类目录:Ⅱ类:17-10-其他口腔材料.
产品信息:氟防龋材料(川械注准20202170057).
","44001","44001","45826","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第16期)(截止2020.
6.
24)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","成都方拓仿真技术有限责任公司","91510100725379927T","林涛","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160001号","产品延续注册后注册证号变更.
骨矿密度测量体模延续注册后,注册号由"川械注准20142330021"变更为"川械注准20142060021.
生产范围由"2002分类目录:Ⅱ类:6831-4-附属设备"变更为"2017分类目录:Ⅱ类:06-05-X射线附属及辅助设备".
","44004","44004","44199","四川省药品监督管理局""2","《医疗器械生产许可证》核发","四川携光生物技术有限公司","91510100MA6C9EGJ37","秦枫","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200023号","新核发.
法定代表人为秦枫;企业负责人为秦枫;住所为成都高新区天河路1号1栋1单元1层9号、10号;生产地址为成都市高新区(西区)天河路1号纵横科技园1栋1单元1层9号房、10号房;生产范围为2002分类目录Ⅱ类:6840--体外诊断试剂.
新核发.
法定代表人为秦枫;企业负责人为秦枫;住所为成都高新区天河路1号1栋1单元1层9号、10号;生产地址为成都市高新区(西区)天河路1号纵横科技园1栋1单元1层9号房、10号房;生产范围为2002分类目录Ⅱ类:6840--体外诊断试剂.
产品信息:抗核糖核蛋白(nRNP/Sm)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400074、抗干燥综合征抗原A(SS-A)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400067、抗PM-Scl抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400066、抗组胺酰tRNA合成酶(Jo-1)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400080、抗核糖体蛋白P0(P0)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400072、抗线粒体2型(AMA-M2)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400075、抗肝肾微粒体1型(LKM-1)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400078、抗史密斯(Sm)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400068、抗干燥综合征抗原B(SS-B/La)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400069、抗Scl-70抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400079、抗核小体(Nuc)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400070、抗组蛋白(His)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400076、抗着丝点蛋白B(CENP-B)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400073、抗肾小球基底膜(GBM)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400063、抗髓过氧化物酶(MPO)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400065、抗蛋白酶3(PR3)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400064、抗双链DNA(dsDNA)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400077、抗可溶性肝抗原/肝胰抗原(SLA/LP)抗体IgG检测试剂盒(磁微粒化学发光法)注册证号为川械注准20202400071.
","44004","44004","45829","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","减少受托生产产品一次性无菌血液回路(国械注准20153451911).
一次性使用血液透析管路(国械注准20183100377),延长受托生产至2022年5月25日.
","44005","44005","45614","四川省药品监督管理局""4","应急审批","四川省宜宾圣山服装家纺有限公司","915115007208716484","王健","普通","《医疗器械生产许可证》(含生产产品登记表)","川药械应急生产许20200003号","生产地址非文字性变更由宜宾罗龙工业集中区滨江东路1号(合成车间)变更为四川省宜宾市临港经开区兴港路西段134号8栋一层、二层","44006","44006","44070","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第17期)(截止2020.
7.
3)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川泰猷科技有限公司","91510100MA61RR7JXK","刘士敏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190004号","增加生产范围(2017年分类)Ⅱ类:18-04-妇产科治疗器械;增加超声产后康复治疗仪,川械注准20202180087.
","44010","44010","45305","四川省药品监督管理局""2","《医疗器械生产许可证》生产地址非文字性变更","爱齐(四川)医疗设备有限公司","91512000MA6AUMYR8R","JulieAnnColetti","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180023号","生产地址非文字性变更由"四川省资阳市现代大道3号D栋1、2层"变更为"四川省资阳市现代大道3号D栋1、2层;四川省资阳市雁江区外环路西三段508号".
","44011","44011","45118","四川省药品监督管理局""3","《医疗器械生产许可证》延续","四川省智能电子实业有限公司","91510100202076847A","吴洪宇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150073号","同意延续.
住所为成都高新区天府大道南段1399号时代天城1号楼22楼11-19号、21号;生产地址为成都高新区天府大道南段1399号时代天城1号楼22楼11-19号、21号;法定代表人为吴洪宇;企业负责人为吴洪宇;产品范围2002分类目录:Ⅱ类:6821-5-脑电诊断仪器,6821-11-医用刺激器.
2017分类目录:Ⅱ类:Ⅱ类:07-03-生理参数分析测量设备,09-01-电疗设备/器具.
","44011","44011","45836","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","四川肾友达科技有限公司","91510112086689645L","曹慕真","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180025号","增加生产产品透析浓缩液(国械注准20203100564)和受托生产产品透析干粉(国械注准20153100219)延续注册后,延长受托生产至2020年10月17日.
","44011","44011","45146","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川港通医疗设备集团股份有限公司","91510100206881448P","陈永","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149014号","产品延续注册后注册证号变更:酸性氧化电位水生成装置延续注册后,注册号由"川械注准20152570176"变更为"川械注准20152110176",生产范围由"2002分类目录:Ⅱ类:6857-6-专用消毒设备"变更为"2017分类目录:Ⅱ类:11-03-化学消毒灭菌设备";2、"医用制氧机"产品名称变更为"医用分子筛制氧系统"、"医用空气压缩机"产品名称变更为"医用空气集中供应系统".
","44011","44011","45474","四川省药品监督管理局""6","《医疗器械生产许可证》延续","成都市牙立方义齿技术有限公司","91510122331958520Y","龚发佳","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160009号","住所由中国(四川)自由贸易试验区成都市双流区西航港开发区黄甲街道黄甲镇杨桥路666号4楼5楼变更为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区龙湖路48号;生产地址非文字性变更由中国(四川)自由贸易试验区成都市双流区西航港开发区黄甲街道黄甲镇杨桥路666号4楼5楼变更为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区龙湖路48号1栋2层","44012","44012","45837","四川省药品监督管理局""7","《医疗器械生产许可证》核发","成都维美义齿制造有限公司","91510100MA69XU34XG","阳彪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200024号","法定代表人为阳彪;企业负责人为舒富强;住所为成都高新区合作路1238号3楼2号;生产地址为成都高新区合作路1238号3楼2号;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿2017分类目录Ⅱ类:17-06-口腔义齿制作材料.
生产产品:1定制式固定义齿川械注准202021700892定制式活动义齿川械注准20202170088","44013","44013","45838","四川省药品监督管理局""8","《医疗器械生产许可证》核发","成都天美牙科技术开发有限公司","91510113MA65LA1E55","冯成林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200025号","法定代表人为冯成林;企业负责人为冯成林;住所为成都市青白江区清泉大道二段6668号(欧洲产业城);生产地址为成都市青白江区清泉大道二段6668号(欧洲产业城)C区1栋4层1号;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿2017分类目录Ⅱ类:17-06-口腔义齿制作材料.
产品信息:1定制式固定义齿川械注准202021700892定制式活动义齿川械注准20202170088.
","44014","44014","45839","四川省药品监督管理局""9","《医疗器械生产许可证》企业名称变更","四川迪耀科技有限公司","91512000MA63P8H4XC","金兑泳","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190048号","企业名称由资阳迪耀科技有限公司变更为四川迪耀科技有限公司;法定代表人由李允基变更为金兑泳;企业负责人由李允基变更为金兑泳.
","44015","44015","45560","四川省药品监督管理局""10","《医疗器械生产许可证》延续","成都科宁达材料有限公司","915101077686235204","李宁","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160008号","同意延续.
住所为成都市科华北路99号(四川大学国家大学科技园);生产地址为成都市龙泉驿区经济技术开发区南一路68号3栋1层3号、2栋1层2号;法定代表人为李宁;企业负责人为李宁;2002分类目录:Ⅱ类:6863-7-金属、陶瓷类义齿材料2017分类目录:Ⅱ类:17-06-口腔义齿制作材料;产品信息1全瓷义齿用氧化锆瓷块川械注准201526301332牙科铸造烤瓷镍铬合金川械注准201726302043牙科烤瓷镍铬合金川械注准201921700944牙科烤瓷钴铬合金川械注准201921700935牙科钴铬支架合金川械注准20192170092.
","44015","44015","45840","四川省药品监督管理局""11","《医疗器械生产许可证》延续","成都悦齿精工科技有限公司","91510112394479236T","陈嘉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150071号","同意延续.
住所为四川省成都经济技术开发区(龙泉驿区)成龙大道二段1666号B2栋2层4号;生产地址为成都经济技术开发区成龙大道二段1666号B2栋2层4号房;法定代表人为陈嘉;企业负责人为陈嘉;2002分类目录Ⅱ类:6863-16-定制式义齿;产品信息1定制式固定义齿川械注准201526300752定制式活动义齿川械注准20152630076.
","44015","44015","45840","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第18期)(截止2020.
7.
10)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","成都普利泰生物科技有限公司","915101003320359631","冉鹏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190014号","增加生产产品:综合Ⅱ生化测定试剂盘(川械注准20202400093);综合Ⅲ生化测定试剂盘(川械注准20202400094)","44018","44018","45364","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都桦恩医疗器械有限责任公司","91510121MA6DG9K68D","刁玉兰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200019号","减少生产范围(2002年分类)Ⅲ类:6810-8-6810-8矫形(骨科)外科用其他器械,6846-1-植入器材;增加生产范围(2002年分类)Ⅱ类:6810-8-矫形(骨科)外科用其它器械;生产范围(2017年分类)Ⅲ类:13-03-脊柱植入物;增加生产产品:椎间融合器(国械注准20203130414)、锁定型金属接骨板(国械注准20203130356)、脊柱后路内固定系统(国械注准20203130557)、空心接骨螺钉(非锁定)(国械注准20203130571).
","44018","44018","45804","四川省药品监督管理局""3","《医疗器械生产许可证》法定代表人变更","成都太合生物材料有限公司","9151013172036104XA","王锐","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150017号","法定代表人由吴锐变更为王锐;企业负责人由吴锐变更为王锐","44018","44018","45516","四川省药品监督管理局""4","《医疗器械生产许可证》法定代表人变更","成都德而塔生物科技有限公司","91510100MA61T9255K","方刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200001号","法定代表人由王俊变更为方刚;企业负责人由王俊变更为陈治钢.
","44019","44019","45663","四川省药品监督管理局""5","《医疗器械生产许可证》核发","四川恩斯特医疗器械有限公司","91512000MA65H61C6T","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200026号","新核发.
法定代表人为何国昆;企业负责人为孙张莉;住所为四川省资阳市雁江区现代大道3号C栋三层C2-E4区;生产地址为四川省资阳市雁江区现代大道3号C栋三层C2-E4区;生产范围为2002分类目录Ⅱ类:6822-6-医用手术及诊断用显微设备2017分类目录Ⅱ类:06-13-光学成像诊断设备.
产品信息1手术显微镜川械注准20202060096.
","44021","44021","45846","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","奥泰医疗系统有限责任公司","91510100771215018D","雷旸","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160024号","增加生产产品:数字化医用X射线摄影系统(川械注准20202060090)","44021","44021","44304","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","老肯医疗科技股份有限公司","915101007130698769","刘霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149006号","增加生产范围(2017年分类)Ⅱ类:11-01-湿热消毒灭菌设备;减少生产产品:内镜清洗设备(川械注准20152570064);脉动真空压力蒸汽灭菌器延续注册后证号由川械注准20152570086变更为川械注准20152110086.
","44021","44021","45595","四川省药品监督管理局""8","《医疗器械生产许可证》法定代表人变更","成都好特医疗器械有限公司","91510124597269845K","宋行","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160019号","法定代表人由吴刚变更为宋行;企业负责人由吴刚变更为宋行.
","44021","44021","44277","四川省药品监督管理局""9","《医疗器械生产许可证》延续","四川博凯医疗电子有限责任公司","915120216602792031","马聪晓","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160003号","法定代表人为马聪晓;企业负责人为李涛;住所为资阳经济技术开发区安岳工业园(安岳县石桥铺镇);生产地址为安岳县岳阳镇工业园区;生产范围为2002分类目录Ⅱ类:6830-2-医用X射线诊断设备.
","44022","44022","45847","四川省药品监督管理局""10","《医疗器械生产许可证》延续","成都方拓仿真技术有限责任公司","91510100725379927T","林涛","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160001号","法定代表人为林涛;企业负责人为林涛;;住所为成都高新区高朋大道5号博士创业园生产地址为成都市青羊区工业集中发展区西区第2#地块第B1栋11号;生产范围为2002分类目录Ⅱ类:6831-4-附属设备2017分类目录Ⅱ类:06-05-X射线附属及辅助设备.
","44022","44022","45847","四川省药品监督管理局""11","《医疗器械生产许可证》延续","乐山市嘉美冠牙科技术有限公司","91511100662761853B","吴桂英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160005号","法定代表人为吴桂英;企业负责人为吴桂英;住所为乐山市市中区牟子镇沟儿口村二组;生产地址为乐山市市中区牟子镇沟儿口村二组;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿.
","44022","44022","45847","四川省药品监督管理局""12","《医疗器械生产许可证》生产地址非文字性变更","卡瓦(四川)医疗器械有限公司","91512000MA66NA1L43","侯刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190002号","生产地址非文字性变更由四川省资阳市现代大道3号A栋一层E2、F区,二层楼A、B、C区变更为四川省资阳市现代大道3号A栋一层D、E-1、E2、F区,二层楼A、B、C区.
","44022","44022","45298","四川省药品监督管理局""13","《医疗器械生产许可证》延续","四川南格尔生物科技有限公司","91510185071405021T","刘仁明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160004号","法定代表人为刘仁明;企业负责人为杨勇;住所为简阳市东溪镇奎星路28号;生产地址为1、四川省简阳市东溪镇奎星路28号;2、成都高新区庆云村五组55号石羊工业园2#厂房四层;生产范围为2002分类目录Ⅲ类:6845-4-血液净化设备和血液净化器具,6845-6-体液处理设备,6866-1-输液、输血器具及管路2017分类目录Ⅲ类:10-01-血液分离、处理、贮存设备,10-02-血液分离、处理、贮存器具.
","44022","44022","45847","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第19期)(截止2020.
7.
24)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》生产地址非文字性变更","四川携光生物技术有限公司","91510100MA6C9EGJ37","秦枫","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200023号","住所由成都高新区天河路1号1栋1单元1层9号、10号变更为成都高新区天河路1号1栋1单元1层1室9号、10号;生产地址非文字性变更由成都市高新区(西区)天河路1号纵横科技园1栋1单元1层9号房、10号房变更为成都市高新区(西区)天河路1号1栋1单元1层1室9号、10号、11号.
","44032","44032","45829","四川省药品监督管理局""2","《医疗器械生产许可证》核发","四川科瑞德美地亚医疗器械有限公司","91510500MA66H2EN9Y","陈刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200027号","新核发.
法定代表人为陈刚;企业负责人为陈刚;住所为四川省泸州市泸县玉蟾街道曲河西路9号1幢1号;生产地址为四川省泸州市泸县玉蟾街道曲河西路9号1幢1号;生产范围为2002分类目录Ⅱ类:6821-4-心电诊断仪器2017分类目录Ⅱ类:07-03-生理参数分析测量设备.
产品信息:心率变异分析仪川械注准20202070102.
","44032","44032","45857","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都科宁达材料有限公司","915101077686235204","李宁","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160008号","增加生产产品:牙科用可摘义齿钴铬合金(川械注准20202170061)","44034","44034","44214","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都开创义齿技术有限责任公司","91510100396288169W","王巍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160014号","增加生产范围(2017年分类)Ⅱ类:17-06-口腔义齿制作材料;定制式固定义齿的注册证号由川械注准20152630066变更为川械注准20152170066;定制式活动义齿的注册证号由川械注准20152630067变更为川械注准20152170067.
","44034","44034","44272","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品促卵泡生成素测定试剂盒(直接化学发光法)川械注准20202400084;泌乳素测定试剂盒(直接化学发光法)川械注准20202400086;孕酮测定试剂盒(直接化学发光法)川械注准20202400095;促黄体生成素测定试剂盒(直接化学发光法)川械注准20202400098;β-人绒毛膜促性腺激素测定试剂盒(直接化学发光法)川械注准20202400099;甲状腺球蛋白测定试剂盒(直接化学发光法)川械注准20202400100;降钙素测定试剂盒(直接化学发光法)川械注准20202400101.
","44034","44034","44067","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","四川空分医用设备工程股份有限公司","91512081206850713M","黄凯","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150065号","增加生产范围(2017年分类)08-07-医用供气排气相关设备,14-06-与非血管内导管配套用体外器械;增加生产产品:医用空气压缩机,川械注准20202080091;医用真空负压机,川械注准20202080092.
","44036","44036","45755","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川康宁医用器材有限公司","91511126207506236U","朱良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150055号","增加生产范围(2017年分类)Ⅱ类:14-01-注射、穿刺器械Ⅲ类:14-01-注射、穿刺器械,14-02-血管内输液器械;产品延续注册后证号变更:一次性使用无菌注射器带针注册证号由国械注准20153151081变更为国械注准20153141081;一次性使用输液器带针注册证号由国械注准20153662176变更为国械注准20153142176;一次性使用静脉输液针注册证号由国械注准20153152173变更为国械注准20153142173.
","44036","44036","45627","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150057号","减少生产范围(2002年分类)Ⅱ类:6808-6-一次性使用直线型切割缝合器,6808-6-一次性使用直线缝合器,6866-5-呼吸麻醉或通气用气管插管,新增生产范围(2002年分类)Ⅱ类:6866-4-导管、引流管.
麻醉回路的的注册证号由川械注准20142660005变更为川械注准20142080005;一次性使用直线型切割缝合器的注册证号由川械注准20142080010变更为川械注准20142020011;一次性使用直线型缝合器的注册证号由川械注准20142080011变更为川械注准20142020010;增加生产产品一次性使用引流袋川械注准20162660276.
","44036","44036","45726","四川省药品监督管理局""9","《医疗器械生产许可证》延续","成都琢美义齿技术有限公司","91510122587590619G","许可","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160022号","同意延续.
住所为成都市双流区西航港大道中四段204、206、208号;生产地址为成都市双流区西航港大道中四段204、206、208号;法定代表人为许可;企业负责人为许可;生产范围(2002年分类)Ⅱ类:6863-16-定制式义齿生产产品:1定制式固定义齿川械注准201626301492定制式活动义齿川械注准20162630150","44036","44036","45861","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第20期)(截止2020.
7.
31)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》生产地址非文字性变更","成都迪康中科生物医学材料有限公司","915101007203615413","李晓萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150048号","生产地址非文字性变更由成都高新区西部园区迪康大道1号1幢1F;成都高新区西部园区迪康大道1号1幢2F;成都高新区西部园区迪康大道1号6栋1层1号4F变更为成都高新区西部园区迪康大道1号1幢1F;成都高新区西部园区迪康大道1号1幢2F;成都高新区西部园区迪康大道1号3栋;成都高新区西部园区迪康大道1号6栋1层1号4F.
","44040","44040","45617","四川省药品监督管理局""2","《医疗器械生产许可证》核发","四川制药制剂有限公司","91510100777457202W","沈山","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200028号","新核发.
法定代表人为沈山;企业负责人为梅圣亮;住所为成都市高新西区百叶路18号;生产地址为四川省成都市高新西区百叶路18号802一楼,805四楼,201三、四楼;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品1一次性使用医用口罩川械注准202021401042医用外科口罩川械注准20202140103","44041","44041","45865","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都威力生生物科技有限公司","91510100794916300L","陈贵文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160053号","血液透析机(注册证号为国械注准20173454272)产品名称变更为血液透析设备.
","44041","44041","44477","四川省药品监督管理局""4","《医疗器械生产许可证》核发","眉山尤博瑞新材料有限公司","91511400MA6AWEN73P","谭遂丹","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200029号","新核发.
法定代表人为谭遂丹;企业负责人为谭鸿;住所为四川省眉山市东坡区眉山高新技术产业园区金泰路1号D2幢;生产地址为四川省眉山市东坡区眉山高新技术产业园区金泰路1号D2幢;生产范围为2002分类目录Ⅱ类:6866-3-避孕器械2017分类目录Ⅱ类:18-06-妊娠控制器械;生产产品1聚氨酯避孕套川械注准20202180105.
","44043","44043","45868","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川拜阿蒙生物活性材料有限责任公司","91510100201990565A","朱向东","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150049号","增加生产范围(2017年分类)13-04-关节置换植入物;羟基磷灰石粉料的注册证号由国械注准20153630860变更为国械注准20153130860;增加生产产品人工髋关节(国械注准20203131508),该产品原注册证编号为国食药监械(准)字2014第3461566号于2019年9月4日到期,现取得延续注册后予以增加.
","44043","44043","45753","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第21期)(截止2020.
8.
13)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》核发","成都匠心汇医疗科技有限公司","91510112MA6BLAKN5L","王涛","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200030号","新核发.
法定代表人为王涛;企业负责人为王涛;住所为四川省成都经济技术开发区(龙泉驿区)成龙大道二段1666号D2栋5层3号附2号;生产地址为四川省成都经济技术开发区(龙泉驿区)成龙大道二段1666号D2栋5层3号附2号;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿2017分类目录Ⅱ类:17-06-口腔义齿制作材料;生产产品1定制式固定义齿川械注准20202170081.
","44046","44046","45871","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都迪康中科生物医学材料有限公司","915101007203615413","李晓萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150048号","增加生产范围(2017年分类)Ⅲ类:14-08-可吸收外科敷料(材料);可吸收医用膜的注册证号由国械注准20153640964变更为国械注准20153140964.
","44046","44046","45617","四川省药品监督管理局""3","《医疗器械生产许可证》生产地址非文字性变更","四川金佳钲医疗器械有限公司","91510502MA622C046A","梁熙","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190027号","住所由四川省泸州市江阳区兴园路6号二楼E区F区变更为四川省泸州市泸县玉蟾街道新坪路西段18号附5号1层、2层B区;生产地址非文字性变更由四川省泸州市江阳区兴园路6号二楼E区F区变更为四川省泸州市泸县玉蟾街道新坪路西段18号附5号1层、2层B区.
","44046","44046","45461","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市研美义齿技术有限公司","915101073940996639","郭丹","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170043号","增加生产范围(2017年分类)Ⅱ类:17-06-口腔义齿制作材料;产品延续注册后证号变更:定制式固定义齿的注册证号由川械注准20152630073变更为川械注准20152170073;定制式活动义齿的注册证号由川械注准20152630074变更为川械注准20152170074.
","44046","44046","44900","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都卓越义齿技术有限公司","91510122782668565G","刘晓","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160011号","增加生产范围(2017年分类)Ⅱ类:17-06-口腔义齿制作材料;产品延续注册后证号变更:定制式固定义齿的注册证号由川械注准20152630042变更为川械注准20152170042;定制式活动义齿的注册证号由川械注准20152630043变更为川械注准20152170043.
","44049","44049","44240","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省菲娅医疗器械有限公司","91512000MA67838U2F","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190061号","增加生产产品铜镍钛正畸丝(川械注准20202170113).
","44053","44053","45617","四川省药品监督管理局""7","《医疗器械生产许可证》企业住所变更","四川霖优生物科技有限公司","91510100321603005F","郭宝刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190046号","住所由"成都高新区(西区)西芯大道17号"变更为"成都市温江区成都海峡两岸科技产业开发园双堰路1919号7号楼1-4层".
","44053","44053","45539","四川省药品监督管理局""8","《医疗器械生产许可证》延续","成都开创义齿技术有限责任公司","91510100396288169W","王巍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160014号","同意延续.
住所为成都市高新区西部园区百草路9号3幢1层2号厂房;生产地址为成都市高新区西部园区百草路9号3幢1层2号厂房;法定代表人为王巍;企业负责人为王巍;生产范围(2002分类目录:Ⅱ类:6863-16-定制式义齿;2017年分类目录:Ⅱ类:17-06-口腔义齿制作材料.
生产产品:1、定制式固定义齿川械注准20152170066;2、定制式活动义齿川械注准20152170067).
","44055","44055","45880","四川省药品监督管理局""9","《医疗器械生产许可证》生产地址非文字性变更","爱齐(四川)医疗设备有限公司","91512000MA6AUMYR8R","JulieAnnColetti","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180023号","生产地址非文字性变更由四川省资阳市现代大道3号D栋1、2层;四川省资阳市雁江区外环路西三段508号变更为四川省资阳市现代大道3号D栋1、2、3层;四川省资阳市雁江区外环路西三段508号.
","44055","44055","45118","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第22期)(截止2020.
8.
31)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》法定代表人变更","中国核动力研究设计院设备制造厂","915111269075114823","万钢","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150066号","法定代表人由"罗绮"变更为"万钢".
","44060","44060","45008","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都迪康中科生物医学材料有限公司","915101007203615413","李晓萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150048号","增加生产范围(2017年分类)Ⅲ类:13-01-骨接合植入物;产品延续注册后证号变更:可吸收骨折内固定螺钉的注册证号由"国械注准20153461906"变更为"国械注准20153131906".
","44056","44056","45617","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市宏盛义齿技术有限公司","91510124343041306X","杨辉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160017号","增加生产范围(2017年分类)Ⅱ类:17-06-口腔义齿制作材料;产品延续注册后证号变更:定制式固定义齿的注册证号由"川械注准20152630150"变更为"川械注准20152170150";定制式活动义齿的注册证号由"川械注准20152630149"变更为"川械注准20152170149".
","44056","44056","20213-22","四川省药品监督管理局""4","《医疗器械生产许可证》企业住所变更","成都开创义齿技术有限责任公司","91510100396288169W","王巍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160014号","住所由"成都市高新区西部园区百草路9号3幢1层2号厂房"变更为"成都高新区西部园区百草路993号3幢1层2号厂房";生产地址文字性变更由"成都市高新区西部园区百草路9号3幢1层2号厂房"变更为"成都高新区西部园区百草路993号3幢1层2号厂房".
","44062","44062","45880","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川阿尔泰医疗器械有限公司","91510681665385216T","黄永兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160025号","增加生产范围(2017年分类)Ⅲ类:13-03-脊柱植入物;产品延续注册后证号变更:脊柱内固定系统的注册证号由"国械注准20153461023"变更为"国械注准20153131023".
","44067","44067","44307","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","四川新健康成生物股份有限公司","9151010079780219XP","王大平","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170002号","产品延续注册后证号变更:全自动生化分析仪的注册证号由"川械注准20152400174"变更为"川械注准20152220174".
","44067","44067","44573","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川沃文特生物技术有限公司","91510100577371682N","杨龙贤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150063号","增加生产产品:葡萄糖测定试剂盒(己糖激酶法),注册证号"川械注准20202400110"、血清淀粉样蛋白A测定试剂盒(胶乳免疫比浊法),注册证号"川械注准20202400111"、尿总蛋白测定试剂盒(邻苯三酚红钼法),注册证号"川械注准20202400112".
","44067","44067","45726","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","资阳频泰医疗设备有限公司","91512000MA64Y2CA0R","敖明武","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200020号","增加受托生产产品:口腔数字印模仪(皖械注准20202170383)","44068","44068","45822","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","四川携光生物技术有限公司","91510100MA6C9EGJ37","秦枫","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200023号","增加生产产品:抗sp100抗体IgG检测试剂盒(磁微粒化学发光法)(川械注准20202400106)、抗肝细胞溶质抗原1型(LC-1)抗体IgG检测试剂盒(磁微粒化学发光法)(川械注准20202400108)、抗增殖细胞核抗原(PCNA)抗体IgG检测试剂盒(磁微粒化学发光法)(川械注准20202400107)、抗Ro52抗体IgG检测试剂盒(磁微粒化学发光法)(川械注准20202400109).
","44068","44068","45829","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","中青康源成都医疗技术有限公司","91510100MA62MYKP47","蒲丹","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190024号","增加生产范围(2017年分类)Ⅱ类:07-03-生理参数分析测量设备;增加首次注册产品:医用红外体温计(川械注准20202070122).
","44069","44069","45454","四川省药品监督管理局""11","《医疗器械生产许可证》增加生产范围/增加生产产品","四川普瑞斯生物科技有限公司","91511503563252148F","雷冰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170033号","增加生产范围(2017年分类)Ⅱ类:14-02-血管内输液器械,14-13-手术室感染控制用品,14-14-医护人员防护用品;增加首次注册产品:一次性使用防针刺静脉留置针(国械注准20203140162)、一次性使用精密过滤避光输液器带针(国械注准20203140514)、一次性使用避光袋式输液器带针(国械注准20203140648)、一次性使用避光输液器带针(国械注准20203140515)、一次性使用精密过滤避光袋式输液器带针(国械注准20203140608)、一次性使用输液器带针(国械注准20203140661)、医用防护口罩(川械注准20202140114)、医用外科口罩(川械注准20202140115).
","44069","44069","44824","四川省药品监督管理局""12","《医疗器械生产许可证》核发","成都澳若思医疗器械有限公司","91510123MA6ADG5B34","何永","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200031号","新核发.
法定代表人为何永;企业负责人为翟辉林;住所成都市温江区成都海峡两岸科技产业开发园青啤大道319号中小企业孵化园8-2-601号;生产地址为成都市温江区成都海峡两岸科技产业开发园青啤大道319号中小企业孵化园8-2-601号;生产范围为2002分类目录:Ⅱ类:6863-16-定制式义齿;2017年分类:Ⅱ类:Ⅱ类:17-06-口腔义齿制作材料.
生产产品1、定制式固定义齿"川械注准20202170117";2、定制式活动义齿"川械注准20202170118".
","44069","44069","45894","四川省药品监督管理局""13","《医疗器械生产许可证》企业负责人变更","四川大爱科技有限公司","915107000541263113","夏元林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170030号","企业负责人由罗成变更为程粒.
","44070","44070","44795","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第23期)(截止2020.
9.
14)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市万福实业工程有限公司","915101247092429206","高原","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150015号","产品延续注册后证号变更:医用中心供氧系统的注册证号由"川械注准20152560091"变更为"川械注准20152080091",医用中心吸引系统的注册证号由"川械注准20152540092"变更为"川械注准20152140092".
","44076","44076","45539","四川省药品监督管理局""2","《医疗器械生产许可证》延续","成都卓越义齿技术有限公司","91510122782668565G","刘晓","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160011号","同意延续.
住所为成都双流西南航空港经济开发区空港二路361号;生产地址为成都双流西南航空港经济开发区空港二路361号附327号、329号、331号;法定代表人为刘晓,企业负责人为陈勇珍;生产范围(2002年分类):Ⅱ类:6863-16-定制式义齿;(2017年分类录:Ⅱ类:17-06-口腔义齿制作材料.
生产产品:1.
定制式固定义齿川械注准20152170042;2.
定制式活动义齿川械注准20152170043.
","44076","44076","45901","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市艺境义齿技术有限公司","91510108075368598X","姚晓明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160021号","1、增加生产范围:2017年分类:Ⅱ类:17-06-口腔义齿制作材料;产品延续注册后证号变更:定制式活动义齿的注册证号由"川食药监械(准)字2014第2630006号"变更为"川械注准20172630245",定制式固定义齿的注册证号由"川食药监械(准)字2014第2630007号"变更为"川械注准20172630246"2、住所由"成都市成华区东三环路二段龙潭工业园成致路48号"变更为"四川省成都市成华区东三环路二段龙潭工业园成致路48号".
","44076","44076","44278","四川省药品监督管理局""4","《医疗器械生产许可证》生产地址非文字性变更","四川南格尔生物科技有限公司","91510185071405021T","刘仁明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160004号","生产地址非文字性变更由"1、四川省简阳市东溪镇奎星路28号;2、成都高新区庆云村五组55号石羊工业园2#厂房四层"变更为"1、四川省简阳市东溪镇奎星路28号;2、成都市高新区益新大道288号石羊工业园2#厂房四层401号、402号".
","44076","44076","45847","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都博奥晶芯生物科技有限公司","91510115577375018L","宋云鹏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150041号","减少生产产品:六项呼吸道病毒核酸检测试剂盒(恒温扩增芯片法),注册证号"国械注准20203400178".
","44076","44076","45601","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克医疗电子有限公司","91510100590236741G","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170038号","产品延续注册后证号变更:全自动凝血分析仪的注册证号由"川械注准20152400117"变更为"川械注准20152220117",干式荧光免疫分析仪的注册证号由"川械注准20152400118"变更为"川械注准20152220118".
","44081","44081","44874","四川省药品监督管理局""7","《医疗器械生产许可证》生产地址非文字性变更","四川友邦企业有限公司","91510681620881275N","高尚荣","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170008号","生产地址非文字性变更由"德阳广汉高新技术产业园区向阳镇向兴路37号"变更为"1、德阳广汉高新技术产业园区向阳镇向兴路37号2、四川省德阳市广汉市经济开发区(南区)友邦工业园8#车间3、四川省德阳市广汉市北京大道三段同心路30号生产车间大楼1楼".
","44081","44081","44628","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","成都恩普生医疗科技有限公司","91510100669654620X","昝学全","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150042号","增加生产范围:2017年分类、:Ⅱ类:07-04-监护设备;增加生产产品:心率带(川械注准20202070097).
","44081","44081","45652","四川省药品监督管理局""9","《医疗器械生产许可证》生产地址非文字性变更","儒蓉(成都)医疗科技有限公司","91510100MA6CE4W85M","CHANQIANWANG","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200021号","生产地址非文字性变更由"中国(四川)自由贸易试验区成都高新区天府大道北段1480号1栋A-4-35号'变更为"中国(四川)自由贸易试验区成都高新区和民街16号8号楼6层601、602号房";住所由"中国(四川)自由贸易试验区成都高新区天府大道北段1480号1栋A-4-35号"变更为"中国(四川)自由贸易试验区成都高新区和民街16号8号楼6层601、602号房".
","44081","44081","45822","四川省药品监督管理局""10","《医疗器械生产许可证》延续","成都市宏盛义齿技术有限公司","91510124343041306X","杨辉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160017号","同意延续.
住所为郫县成都现代工业港北片区港中路188号;生产地址为郫县成都现代工业港北片区港中路188号3栋2楼;法定代表人为杨辉,企业负责人为孙强;生产范围(2002年分类):Ⅱ类:6863-16-定制式义齿;(2017年分类录:Ⅱ类:17-06-口腔义齿制作材料.
生产产品:1.
定制式固定义齿川械注准20152170150;2.
定制式活动义齿川械注准20152170149.
","44081","44081","45906","四川省药品监督管理局""11","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","增加生产产品:医用一次性防护服,注册证号:川械注准20202140127.
","44082","44082","45614","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","四川千里倍益康医疗科技股份有限公司","91510108629517429X","张文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150040号","增加生产产品:中频治疗器,注册证号:川械注准20202090126.
","44084","44084","45614","四川省药品监督管理局""13","《医疗器械生产许可证》增加生产范围/增加生产产品","四川普瑞斯生物科技有限公司","91511503563252148F","雷冰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170033号","增加生产产品:一次性使用医用口罩,注册证号:川械注准20202140125.
","44084","44084","44824","四川省药品监督管理局""14","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:白介素-6测定试剂盒(直接化学发光法),注册证号:20202400116.
","44084","44084","45687","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第24期)(截止2020.
9.
21)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》法定代表人变更","四川昱峰医疗器械有限公司","91510122762296565T","罗红尧","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170016号","法定代表人由"李昌会"变更为"罗红尧".
","44088","44088","44682","四川省药品监督管理局""2","《医疗器械生产许可证》企业住所变更","成都市宏盛义齿技术有限公司","91510124343041306X","杨辉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160017号","住所由"郫县成都现代工业港北片区港中路188号"变更为"成都市郫都区成都现代工业港北片区港中路188号";生产地址文字性变更由"郫县成都现代工业港北片区港中路188号"变更为"成都市郫都区成都现代工业港北片区港中路188号".
","44092","44092","45175","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都艾科斯伦医疗科技有限公司","915101226988525032","夏斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150051号","增加生产产品:干式荧光免疫分析仪,注册证号:川械注准20202220121.
","44092","44092","45691","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都安睿康医疗科技有限公司","915101127528360384","庞开胜","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170001号","增加生产范围(2017年分类)Ⅱ类:08-07-医用供气排气相关设备,14-06-与非血管内导管配套用体外器械;产品延续注册后证号变更:医用中心供氧系统的注册证号由"川食药监械(准)字2014第2560129号"变更为"川械注准20192080197"、医用中心吸引系统的注册证号由"川食药监械(准)字2014第2540128号"变更为"川械注准20192140198".
","44092","44092","44573","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川南格尔生物科技有限公司","91510185071405021T","刘仁明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160004号","增加生产范围(2017年分类)Ⅲ类:14-02-血管内输液器械;产品延续注册后证号变更:一次性使用输液器带针的注册证号由"国械注准20153660636"变更为"国械注准20153140636"、一次性使用单采血细胞分离器的注册证号由"国械注准20153450635"变更为"国械注准20153100635"、红细胞处理仪的注册证号由"国械注准20153451580"变更为"国械注准20153101580".
","44092","44092","45847","四川省药品监督管理局""6","《医疗器械生产许可证》核发","四川星皓医疗器械有限公司","91512000MA65ED784X","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许2020032号","新核发.
法定代表人为何国昆;企业负责人为洪宝安;住所四川省资阳市现代大道3号C栋三层C2-E1区;生产地址为四川省资阳市现代大道3号C栋三层C2-E1区;生产范围为2002分类目录:Ⅱ类:6855-6-车针;2017年分类:Ⅱ类:17-04-口腔治疗器具.
生产产品:牙科金刚砂车针"川械注准20202170137".
","44092","44092","45917","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川立辰医疗器械有限公司","9151012205748144X4","张立","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190026号","增加生产范围(2017年分类)Ⅱ类:,14-10-创面敷料;增加生产产品:伤口敷贴(川械注准20202140007)和聚氨酯泡沫敷料(20202140027).
","44092","44092","45461","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","四川海汇药业有限公司","91510122062401950W","徐镜人","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190058号","增加生产产品:一次性使用加强型气管插管(川械注准20202080133).
","44092","44092","45601","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第25期)(截止2020.
10.
9)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》核发","成都百裕玛仕柯医疗用品制造有限公司","91510115MA68YPKKXT","高志文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200033号","新核发.
法定代表人为高志文;企业负责人为高志文;住所为成都市温江区成都海峡两岸科技产业开发园柳台大道西段433号;生产地址为成都市温江区成都海峡两岸科技产业开发园柳台大道西段433号A12.
生产范围为2002分类目录:Ⅱ类:6864-2-敷料、护创材料;2017年分类:Ⅱ类:14-14-医护人员防护用品.
生产产品:1一次性使用医用口罩"川械注准20202140138";2、医用防护口罩"川械注准20202140139".
","44096","44096","45921","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","减少生产产品:丙氨酸氨基转移酶测定试剂盒(丙氨酸底物法)(川械注准20152400127);胱抑素C测定试剂盒(胶乳免疫比浊法)(川械注准20152400120);γ-谷氨酰基转移酶测定试剂盒(GCANA底物法)(川械注准20152400130);总胆红素测定试剂盒(氧化法)(川械注准20152400121);前白蛋白测定试剂盒(免疫比浊法)(川械注准20152400124);肌酐测定试剂盒(肌氨酸氧化酶法)(川械注准20152400126);总胆汁酸测定试剂盒(酶循环法)(川械注准20152400122);同型半胱氨酸测定试剂盒(酶循环法)(川械注准20152400129);腺苷脱氨酶测定试剂盒(过氧化物酶法)(川械注准20152400125);甘油三酯测定试剂盒(GPO-PAP法)(川械注准20152400123);二氧化碳测定试剂盒(PEPC酶法)(川械注准20152400119);增加生产产品:乙型肝炎病毒前S1抗原质控品(国械注准20203400711).
","44097","44097","45687","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都恩普生医疗科技有限公司","91510100669654620X","昝学全","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150042号","增加生产产品:医用红外体温计,川械注准20202070141;增加生产范围Ⅱ类:07-03-生理参数分析测量设备.
","44097","44097","45652","四川省药品监督管理局""4","《医疗器械生产许可证》企业住所变更","成都云卫康医疗科技有限公司","91510100091283746E","刘俊","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160047号","住所由成都高新区益州大道中段1858号天府软件园G区3栋10层1001、1002号变更为中国(四川)自由贸易试验区成都高新区益州大道中段1858号天府软件园G区3栋10层1001、1002号生产地址文字性变更由1.
成都市郫都区成都现代工业港北片区港通北三路211号3栋1楼107;2.
高新区益州大道中段1858号天府软件园G区3栋10层1001、1002号变更为1.
成都市郫都区成都现代工业港北片区港通北三路211号3栋1楼107;2.
中国(四川)自由贸易试验区成都高新区益州大道中段1858号天府软件园G区3栋10层1001、1002号","44097","44097","44416","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川维思达医疗器械有限公司","915105213269564325","周宗国","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190023号","增加生产产品:颈椎前路固定系统,国械注准20203130697;金属锁定接骨板,国械注准20203130716.
增加生产范围Ⅲ类:13-01-骨接合植入物,13-03-脊柱植入物.
","44099","44099","45439","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","成都稳健利康医疗用品有限公司","9151010068902831X0","杨宁宁","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150008号","产品延续注册后变更:一次性使用手术衣注册证号由川械注准20152640154变更为川械注准20152140154;医用口罩(非外科用)产品名称变更为一次性使用医用口罩,注册证号由川械注准20152640153变更为川械注准20152140153;外科纱布敷料注册证号川械注准20152640177变更为川械注准20152140177.
增加生产范围:2017年分类Ⅱ类:14-09-不可吸收外科敷料,14-13-手术室感染控制用品,14-14-医护人员防护用品.
","44099","44099","45448","四川省药品监督管理局""7","《医疗器械生产许可证》核发","四川杨天生物药业股份有限公司","915100006216084145","张作","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200034号","新核发.
法定代表人为张作;企业负责人为张作;住所为成都市高新西区百叶路39号;生产地址为成都市高新西区百叶路39号15栋A、15栋B、5栋、9栋、2栋1楼.
生产范围为2002分类目录:Ⅱ类:6864-2-敷料、护创材料;2017年分类:Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品.
生产产品:1、一次性使用医用口罩"川械注准20202140146";2、医用外科口罩"20202140147".
","44098","44098","45923","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","绵阳美科电子设备有限责任公司","91510700MA6242UH7Q","赵文军","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150018号","增加生产产品:尿流率仪,川械注准20202070144;膀胱扫描仪图文工作站软件,川械注准20202210143.
增加生产范围:Ⅱ类:07-09-其他测量、分析设备,21-02-影像处理软件.
","44101","44101","45576","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","四川沃文特生物技术有限公司","91510100577371682N","杨龙贤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150063号","增加生产产品:血清淀粉样蛋白A测定试剂盒(化学发光法),川械注准20202400130;白介素-6测定试剂盒(化学发光法),川械注20202400131;人生长激素测定试剂盒(化学发光法),川械注准20202400132.
","44102","44102","45726","四川省药品监督管理局""10","《医疗器械生产许可证》核发","成都善嘉生物医药有限责任公司","915101325800089995","周乃彤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200035号","新核发.
法定代表人为周乃彤;企业负责人为周乃彤;住所为成都市新津县金华镇杨园西路255号;生产地址为成都市新津区普兴街道杨园西路255号B区;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品.
生产产品1医用外科口罩川械注准20202140129;2一次性使用医用口罩川械注准20202140128.
","44103","44103","45928","四川省药品监督管理局""11","《医疗器械生产许可证》核发","宜宾丽雅新材料有限责任公司","91511500MA69NFPCXE","邓传东","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200036号","新核发.
法定代表人为邓传东;企业负责人为贺敏;住所为四川省宜宾市叙州区莱茵河畔月光半岛商业独幢1幢1-3层;生产地址为四川省宜宾市叙州区盐坪坝工业园区医卫楼;生产范围为2002分类目录:Ⅱ类:6864-2-敷料、护创材料;2017分类目录:Ⅱ类:14-14-医护人员防护用品.
生产产品:一次性使用医用口罩,川械注准20202140155.
","44104","44104","45929","四川省药品监督管理局""12","《医疗器械生产许可证》生产地址非文字性变更","成都汇声科技有限公司","915101003320813372","刘刚强","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170018号","生产地址非文字性变更由成都高新区西部园区迪康大道1号1幢1F;成都高新区西部园区迪康大道1号1幢2F;成都高新区西部园区迪康大道1号6栋1层1号4F变更为成都高新区西部园区迪康大道1号1幢1F;成都高新区西部园区迪康大道1号1幢2F;成都高新区西部园区迪康大道1号3栋;成都高新区西部园区迪康大道1号6栋1层1号4F.
","44104","44104","44718","四川省药品监督管理局""13","《医疗器械生产许可证》核发","成都艾伟孚生物科技有限公司","91510100MA62Q1A67H","刘洪君","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200037号","法定代表人为刘洪君;企业负责人为刘洪君;住所为四川省成都市天府新区新兴街道天工大道916号A2栋3-4层;生产地址为四川省成都市天府新区新兴街道天工大道916号A2栋3-4层;生产范围为2002分类目录Ⅲ类:6854-1-手术及急救装置2017分类目录Ⅲ类:18-07-辅助生殖器械.
生产产品1辅助生殖培养用油国械注准20203180689.
","44104","44104","45929","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第26期)(截止2020.
10.
12)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川南格尔生物科技有限公司","91510185071405021T","刘仁明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160004号","产品延续注册后变更:一次性使用单采血液成份分离器注册证号由国械注准20153451686变更为国械注准20153101686.
","44114","44114","45847","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都贝施美生物科技有限公司","915101120866763342","鄢新章","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160041号","增加生产产品牙科钛合金(川械注准20202170150);全瓷义齿用氧化锆彩色瓷块(川械注准20202170149);全瓷义齿用二硅酸锂玻璃陶瓷瓷块(川械注准20202170148).
","44114","44114","44388","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川海汇药业有限公司","91510122062401950W","徐镜人","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190058号","增加生产范围14-05-非血管内导(插)管;增加生产产品:一次性使用鼻胆引流管,川械注准20202140159.
","44114","44114","45601","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第27期)(截止2020.
10.
16)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川沃文特生物技术有限公司","91510100577371682N","杨龙贤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150063号","增加生产产品:小而密低密度脂蛋白胆固醇测定试剂盒(直接清除法)(川械注准20202400134)、抗甲状腺过氧化物酶抗体测定试剂盒(化学发光法)(川械注准20202400135)、抗甲状腺球蛋白抗体测定试剂盒(化学发光法)(川械注准20202400136)、泌乳素测定试剂盒(化学发光法)(川械注准20202400157).
","44116","44116","45726","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","四川明峰医疗科技有限公司","91510681665385216T","潘华素","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190038号","增加生产产品X射线计算机体层摄影设备(国械注准20203060599);X射线计算机体层摄影设备(国械注准20203060634).
","44116","44116","45503","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","宜宾丽雅新材料有限责任公司","91511500MA69NFPCXE","邓传东","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200036号","增加生产范围14-13-手术室感染控制用品;增加生产产品:医用外科口罩,川械注准20202140161.
","44116","44116","45929","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","四川三和医用材料有限公司","91510121746435609C","梁毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150061号","产品延续注册后变更:医用脱脂纱布的注册证号由川械注准20152640131变更为川械注准20152140131;增加生产产品:医用外科口罩(川械注准20202140163);一次性使用医用口罩(川械注准20202140162).
","44116","44116","45798","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都威力生生物科技有限公司","91510100794916300L","陈贵文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160053号","产品延续注册后变更:透析器复用机的注册证号由川械注准20162450080变更为川械注准20162100080,减少2002年分类Ⅱ类:6845-6-体液处理设备,增加2017年分类Ⅱ类:10-03-血液净化及腹膜透析设备.
","44118","44118","44477","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","四川恒明科技开发有限公司","915101067559967907","廖佳明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180003号","减少生产范围:6820-1-体温计,6826-5-理疗康复仪器;增加生产范围09-01-电疗设备/器具;产品延续注册后变更:电脑中频治疗仪的注册证号由川械注准20152260018变更为川械注准20152090018;数字式电子体温计的注册证号由川械注准20152200016变更为川械注准20152070016.
","44118","44118","44947","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川绵竹鸿基制药有限责任公司","91510683738346526R","廖达成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190047号","增加生产产品:医用防护口罩(川械注准20202140167);一次性使用医用口罩(川械注准20202140166);医用外科口罩(川械注准20202140168);增加生产范围:2017年分类Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品.
","44120","44120","45560","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","成都德信安创新医疗技术有限公司","91510115MA61WU232H","武迪蒙","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190033号","增加生产产品:一次性使用超滑导丝,川械注准20202020124;一次性使用超滑导尿包,川械注准20202140165.
","44120","44120","45497","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第28期)(截止2020.
10.
26)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川双陆医疗器械有限公司","91510100716091200D","陆盘兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150057号","增加生产产品:医用外科口罩,川械注准20202140169;一次性使用医用口罩,川械注准20202140170;增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品.
","44123","44123","45726","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都俊骋机电设备工程有限公司","91510100797831214P","鄢华","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160027号","产品延续注册后证号变更:医用中心供氧系统的注册证号由川食药监械(准)字2014第2560090号变更为川械注准20192080095;医用中心吸引系统的注册证号由川食药监械(准)字2014第2540089号变更为川械注准20192140082;增加生产范围(2017年分类)Ⅱ类:08-07-医用供气排气相关设备,14-06-与非血管内导管配套用体外器械.
","44123","44123","44307","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省广元市康康医疗器械有限公司","915108007298019616","陈晓英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150072号","增加生产产品:医用外科口罩,川械注准20202140158;增加生产范围:2017年分类Ⅱ类:14-13-手术室感染控制用品.
","44123","44123","45756","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","四川维思达医疗器械有限公司","915105213269564325","周宗国","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190023号","增加生产产品:金属带锁髓内钉,国械注准20203130742.
","44123","44123","45439","四川省药品监督管理局""5","《医疗器械生产许可证》延续","南充市顺庆区艺美义齿加工中心","91511302MA6290H824","曾建君","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160023号","同意延续.
住所为南充市顺庆区潆华工业园BD—C地块(华荣路二段168号6幢2楼1号);生产地址为南充市顺庆区潆华工业园BD—C地块(华荣路二段168号6幢2楼1号)法定代表人为曾建君;企业负责人为吕红艳;生产范围(2002年分类)Ⅱ类:6863-16-定制式义齿生产范围(2017年分类)Ⅱ类:17-06-口腔义齿制作材料生产产品:1定制式固定义齿川械注准201726302472定制式活动义齿川械注准20172630248","44123","44123","45948","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","奥泰医疗系统有限责任公司","91510100771215018D","雷旸","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160024号","减少生产产品数字化医用X射线摄影系统(川械注准20152300169);数字化医用X射线摄影系统(川械注准20152300170)数字化医用X射线摄影系统(川械注准20152300171);数字化医用X射线摄影系统(川械注准20152300172);数字乳腺X射线摄影系统(川械注准20162300067).
","44125","44125","44304","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","瑞鹏医疗器械成都有限公司","91510132MA61RL0G4K","于辉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180031号","受托生产血液透析浓缩物(国械注准20173454541);受托生产由2020年10月31日延长至2022年10月29日.
","44125","44125","45174","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","四川锦江电子科技有限公司","915101077348059327","李楚文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150016号","增加生产范围07-03-生理参数分析测量设备;增加生产产品:电生理刺激仪,国械注准20203070681.
","44125","44125","45484","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","四川肾友达科技有限公司","91510112086689645L","曹慕真","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180025号","减少生产产品:透析浓缩液,国械注准20183451535,受托生产2020年10月17日;透析浓缩液,国械注准20173453311,受托生产2020年10月17日;透析干粉,国械注准20153100219,受托生产2020年10月17日;增加生产产品:透析浓缩液,国械注准20183451535,受托生产2022年8月13日;透析浓缩液,国械注准20173453311,受托生产2022年8月13日;透析干粉,国械注准20153100219,受托生产2022年8月13日;增加生产范围(2017年分类)Ⅲ类:10-04-血液净化及腹膜透析器具.
","44125","44125","45146","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省菲娅医疗器械有限公司","91512000MA67838U2F","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190061号","增加生产产品:正畸颊面管,川械注准20202170164.
","44125","44125","45617","四川省药品监督管理局""11","《医疗器械生产许可证》核发","遂宁摩天时代医疗器械有限公司","91510900MA66F2CJ2Y","吴升孟","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200038号","新核发.
法定代表人为吴升孟;企业负责人为陈杰;住所为四川省遂宁市经济技术开发区西宁片区纵一路遂宁摩天时代智能终端产业园3号楼1楼A区、2楼B区;生产地址为四川省遂宁市经济技术开发区西宁片区纵一路3号楼1楼A区、2楼B区;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-14-医护人员防护用品.
生产产品:一次性使用医用口罩,川械注准20202140171.
","44126","44126","45951","四川省药品监督管理局""12","《医疗器械生产许可证》住所变更","四川阿斯特医疗器械有限公司","91510521588365739C","李允顺","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160015号","住所由四川省泸州市泸县城西工业园区C区变更为四川省泸州市泸县城西工业园区C区金鹏路58号","44126","44126","44277","四川省药品监督管理局""13","《医疗器械生产许可证》核发","四川通力达医疗水处理设备有限公司","91510124MA6CP6RJ98","左泽林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200039号","新核发.
法定代表人为左泽林;企业负责人为陈维静;住所为成都市郫都区成都现代工业港北片区小微企业创新园红光镇长生桥路1111号9栋附1号;生产地址为成都市郫都区成都现代工业港北片区小微企业创新园红光镇长生桥路1111号9栋附1号;生产范围为2002分类目录Ⅱ类:6845-8-血液透析用制水设备2017分类目录Ⅱ类:10-03-血液净化及腹膜透析设备;生产产品:血液透析用制水设备,川械注准20202100142.
","44127","44127","45952","四川省药品监督管理局""14","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:轮状病毒、腺病毒抗原检测试剂盒(胶体金法),国械注准20203400753.
","44130","44130","45687","四川省药品监督管理局""15","《医疗器械生产许可证》核发","四川新德嘉伟医疗科技有限公司","91510185MA66F7FXXX","葛景霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200040号","新核发.
法定代表人为葛景霞;企业负责人为徐潇;住所为四川省成都市简阳市简城龙桥村工业园区6幢1层;生产地址为四川省成都市简阳市简城龙桥村工业园区6幢1层;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品1医用外科口罩川械注准20202140180;2一次性使用医用口罩川械注准20202140179.
","44130","44130","45955","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第29期)(截止2020.
11.
9)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》补办","四川省遂宁市康达卫生材料有限公司","91510900708990468B","刘亚西","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160029号","补办.
住所为遂宁市创新工业园区南津南路14号;生产地址为遂宁市创新工业园区南津南路14号3栋;法定代表人为刘亚西;企业负责人为刘亚西;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料生产产品1医用脱脂棉川食药监械(准)字2013第2640181号2脱脂棉纱布川食药监械(准)字2013第2640182号.
","44130","44130","45955","四川省药品监督管理局""2","《医疗器械生产许可证》生产地址非文字性变更","四川友邦企业有限公司","91510681620881275N","高尚荣","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170008号","生产地址非文字性变更由1、德阳广汉高新技术产业园区向阳镇向兴路37号2、四川省德阳市广汉市经济开发区(南区)友邦工业园8#车间3、四川省德阳市广汉市北京大道三段同心路30号生产车间大楼1楼变更为1、德阳广汉高新技术产业园区向阳镇向兴路37号2、四川省德阳市广汉市经济开发区(南区)友邦工业园8#车间3、四川省德阳市广汉市北京大道三段同心路30号生产车间大楼1-3楼.
","44131","44131","44628","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川普瑞斯生物科技有限公司","91511503563252148F","雷冰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170033号","增加生产产品:一次性使用袋式输液器带针,国械注准20203140759.
","44137","44137","44824","四川省药品监督管理局""4","《医疗器械生产许可证》住所变更","成都口口齿科技术有限公司","915101077653580043","陈闻多","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170019号","住所由成都市武侯区武侯新城管委会武青南路33号高新技术创业服务中心305、401变更为成都市武侯区武侯电商产业功能区管委会武青南路33号高新技术创业服务中心305、401","44137","44137","44718","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","四川沃文特生物技术有限公司","91510100577371682N","杨龙贤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150063号","增加生产产品:促黄体生成素测定试剂盒(化学发光法)(川械注准20202400174);卵泡刺激素测定试剂盒(化学发光法)(川械注准20202400175);甲状旁腺激素测定试剂盒(化学发光法)(川械注准20202400176);雌二醇测定试剂盒(化学发光法)(川械注准20202400177);睾酮测定试剂盒(化学发光法)(川械注准20202400178);促黄体生成素测定试剂盒(化学发光法)(川械注准20202400174);卵泡刺激素测定试剂盒(化学发光法)(川械注准20202400175);甲状旁腺激素测定试剂盒(化学发光法)(川械注准20202400176);雌二醇测定试剂盒(化学发光法)(川械注准20202400177);睾酮测定试剂盒(化学发光法)(川械注准20202400178).
","44137","44137","45726","四川省药品监督管理局""6","《医疗器械生产许可证》法定代表人/企业负责人变更","成都悦美义齿制造有限公司","91510114674340626G","敬飞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170042号","法定代表人由王玉蓉变更为敬飞;企业负责人由张钧变更为敬飞.
","44137","44137","44899","四川省药品监督管理局""7","《医疗器械生产许可证》核发","太极集团四川太极制药有限公司","91510122621609724F","吴用彦","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200041号","新核发.
法定代表人为吴用彦;企业负责人为吴用彦;住所为四川省成都市双流区西南航空港经济开发区;生产地址为四川省成都市双流区西南航空港经济开发区腾飞二路319号C幢2区;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-14-医护人员防护用品;生产产品:一次性使用医用口罩川械注准20202140172.
","44141","44141","45966","四川省药品监督管理局""8","《医疗器械生产许可证》补办","成都茵帕蒂义齿制造有限公司","91510122MA61R28L4K","严敏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160056号","补办.
住所为成都市双流区西南航空港经济开发区杨桥路204号B幢四楼;生产地址为成都市双流区西南航空港经济开发区杨桥路204号B幢四楼(2单元);法定代表人为严敏;企业负责人为严敏;生产范围(2002年分类)Ⅱ类:6863-16-定制式义齿;生产产品1定制式固定义齿川械注准201626301512定制式活动义齿川械注准20162630152.
","44139","44139","44500","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第30期)(截止2020.
11.
13)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》核发","成都上下牙科技术开发有限公司","91510122MA6ATQH39J","邹伟阳","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200042号","新核发.
法定代表人为邹伟阳;企业负责人为邹伟阳;住所为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区华府大道四段777号;生产地址为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区华府大道四段777号感知物联网产业园区B13栋3楼右侧;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿2017分类目录Ⅱ类:17-06-口腔义齿制作材料;生产产品1定制式固定义齿川械注准202021701512定制式活动义齿川械注准20202170173.
","44141","44141","45966","四川省药品监督管理局""2","《医疗器械生产许可证》核发","四川舒湛新材料有限公司","915115007208716484","王健","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200043号","新核发.
法定代表人为王健;企业负责人为王健;住所为四川省宜宾市临港开发区港园路西段18号;生产地址为四川省宜宾市临港经开区兴港路西段134号8栋一层、二层;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-14-医护人员防护用品;生产产品:医用一次性防护服,川械注准20202140184.
","44141","44141","45966","四川省药品监督管理局""3","《医疗器械生产许可证》延续","成都好特医疗器械有限公司","91510124597269845K","宋行","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160019号","同意延续.
法定代表人为宋行;企业负责人为宋行;住所为成都市郫县成都现代工业港南片区正港路128号;生产地址为成都市郫县成都现代工业港南片区正港路128号厂房D区2号车间;生产范围为2002分类目录Ⅱ类:6826-5-理疗康复仪器,6864-2-敷料、护创材料,6866-11-雾化吸入器,6866-12-一次性使用切口保护套;生产产品1阴道填塞川械注准201526401752海水鼻腔喷雾器川械注准201826600563一次性使用切口保护套川械注准201826600304热敷贴川械注准20182260031","44144","44144","45969","四川省药品监督管理局""4","《医疗器械生产许可证》延续","晓非齿科(成都)制造有限公司","91510100768620864T","张晓非","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160012号","同意延续.
法定代表人为张晓非;企业负责人为张晓非;住所为四川省成都高新区科园南路88号3栋2层202号;生产地址为四川省成都高新区科园南路88号3栋2层202号;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿2017分类目录Ⅱ类:17-06-口腔义齿制作材料;生产产品1定制式固定义齿川械注准201921701602定制式活动义齿川械注准20192170161","44144","44144","45969","四川省药品监督管理局""5","《医疗器械生产许可证》延续","成都博美医疗用品有限公司","91510122327500007E","章长林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160038号","同意延续.
法定代表人为章长林;企业负责人为张俊龙;住所为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区杨桥路885号2栋3层;生产地址为中国(四川)自由贸易试验区成都市双流区西南航空港经济开发区杨桥路885号2栋3层;生产范围为2002分类目录Ⅱ类:6801-2-一次性使用无菌手术刀,6825-5-高频电极;生产产品1手术电极川械注准201622500812中性电极川械注准201622500843电刀清洁片川械注准201620100854消融电极川械注准20182250090","44144","44144","45969","四川省药品监督管理局""6","《医疗器械生产许可证》延续","四川益均医疗器械有限公司","91510922314429301F","龚德燕","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160010号","同意延续.
法定代表人为龚德燕;企业负责人为龚瑾;住所为射洪县涪江大桥东汇宏德市场5-2;生产地址为射洪县涪江大桥东汇宏德市场5-2;生产范围为2002分类目录Ⅱ类:6863-16-定制式义齿;生产产品1定制式活动义齿川械注准201526301582定制式固定义齿川械注准20152630157.
","44144","44144","45969","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","成都桦恩医疗器械有限责任公司","91510121MA6DG9K68D","刁玉兰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200019号","增加生产范围(2017年分类)Ⅲ类:13-02-运动损伤软组织修复重建及置换植入物;增加生产产品:不可吸收带线锚钉,国械注准20203130696.
","44144","44144","45804","四川省药品监督管理局""8","《医疗器械生产许可证》法定代表人/企业负责人变更","成都茵帕蒂义齿制造有限公司","91510122MA61R28L4K","罗强林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160056号","法定代表人由严敏变更为罗强林;企业负责人由严敏变更为罗强林.
","44144","44144","44500","四川省药品监督管理局""9","医疗器械生产许可证》法定代表人变更","成都博奥晶芯生物科技有限公司","91510115577375018L","高云","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150041号","法定代表人由宋云鹏变更为高云","44144","44144","45601","四川省药品监督管理局""10","《医疗器械生产许可证》企业负责人变更","成都卓越义齿技术有限公司","91510122782668565G","刘晓","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160011号","企业负责人由陈勇珍变更为刘晓","44144","44144","45901","四川省药品监督管理局""11","《医疗器械生产许可证》生产地址非文字性变更","成都科宁达材料有限公司","915101077686235204","李宁","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160008号","生产地址非文字性变更由成都市龙泉驿区经济技术开发区南一路68号3栋1层3号、2栋1层2号变更为成都市龙泉驿区经济技术开发区南一路68号3栋1层3号、2栋1层2号、6栋1层1号;增加生产范围(2017年分类)Ⅲ类:17-06-口腔义齿制作材料;增加生产产品:牙科用激光选区熔化钴铬合金粉,国械注准20203170762.
","44144","44144","44214","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","四川省遂宁市康达卫生材料有限公司","91510900708990468B","刘亚西","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160029号","增加生产范围(2017年分类)Ⅱ类:14-09-不可吸收外科敷料,14-14-医护人员防护用品,14-16-其它器械;增加生产产品:一次性使用医用口罩川械注准20202140140;产品延续注册后变更证号:医用脱脂棉的注册证号由川食药监械(准)字2013第2640181号;脱脂棉纱布的注册证号由川食药监械(准)字2013第2640182号变更为川械注准20182640080.
","44144","44144","45955","四川省药品监督管理局""13","《医疗器械生产许可证》增加生产范围/增加生产产品","四川杏林医疗器械有限公司","91510521595090294H","童世兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160039号","住所由泸县城西工业园B区变更为四川省泸州市泸县玉蟾街道怡园路西段5号1-4幢;企业负责人由邱有才变更为王堂汉;增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;增加生产产品:1.
一次性使用医用口罩,川械注准20202140185;2.
医用外科口罩,川械注准20202140186.
","44144","44144","44382","四川省药品监督管理局""14","《医疗器械生产许可证》注销","四川惟思美医疗科技有限公司","91512000MA66U4X59D","陈悟","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190034号","同意注销《医疗器械生产许可证.
","44144","44144","44382","四川省药品监督管理局""15","《医疗器械生产许可证》增加生产范围/增加生产产品","成都仁天医疗器械有限公司","91510114399143002H","王强","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160055号","增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;增加生产产品:一次性使用医用口罩(川械注准20202140183);医用外科口罩(川械注准20202140193).
","44146","44146","44500","四川省药品监督管理局""16","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:β2-微球蛋白测定试剂盒(胶乳免疫比浊法),川械注准20202400085;糖化血红蛋白质控品,川械注准20202400156.
","44148","44148","44067","四川省药品监督管理局""17","《医疗器械生产许可证》增加生产范围/增加生产产品","成都昌华科技有限责任公司","91510100792152378M","陈昌标","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150010号","增加生产范围(2017年分类)Ⅱ类:14-07-清洗、灌洗、吸引、给药器械;产品延续注册后变更:一次性无菌可控单侧支气管封堵导管注册证号由川械注准20152660156变更为川械注准20152080156.
","44148","44148","45454","四川省药品监督管理局""18","《医疗器械生产许可证》增加生产范围/增加生产产品","四川沃文特生物技术有限公司","91510100577371682N","杨龙贤","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150063号","增加生产产品:孕酮测定试剂盒(化学发光法),川械注准20202400190;总β人绒毛膜促性腺激素测定试剂盒(化学发光法),川械注准20202400191;胰岛素测定试剂盒(化学发光法),川械注准20202400192.
","44146","44146","45726","四川省药品监督管理局""19","《医疗器械生产许可证》增加生产范围/增加生产产品","四川三和医用材料有限公司","91510121746435609C","梁毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150061号","增加生产范围(2017年分类)Ⅱ类:14-16-其它器械;产品延续注册后变更:医用棉签的注册证号由川械注准20152640132变更为川械注准20152140132","44146","44146","45798","四川省药品监督管理局""20","《医疗器械生产许可证》住所人变更","思澜科技(成都)有限公司","91510100584995282B","戴涛(DAITAO)","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160034号","住所由中国(四川)自由贸易试验区四川省成都市高新区益州大道中段1800号移动互联创业大厦1804变更为中国(四川)自由贸易试验区成都市高新区益州大道中段1800号移动互联创业大厦1804","44146","44146","44347","四川省药品监督管理局""21","《医疗器械生产许可证》增加生产范围/增加生产产品","成都华信高科医疗器械有限责任公司","91510124713035326C","陈兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190019号","增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;增加生产产品:医用外科口罩,川械注准20202140189;一次性使用医用口罩,川械注准20202140187.
","44148","44148","45390","四川省药品监督管理局""22","《医疗器械生产许可证》核发","四川金科林医疗产业发展有限公司","91510115MA68YUPP6B","陈柏旭","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200044号","新核发.
法定代表人为陈柏旭;企业负责人为陈柏旭;住所为成都市温江区成都海峡两岸科技产业开发园科林西路618号2区302号、303号;生产地址为成都市温江区成都海峡两岸科技产业开发园科林西路618号2区302号、303号;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-14-医护人员防护用品;生产产品:一次性使用医用口罩,川械注准20202140199.
","44146","44146","45971","四川省药品监督管理局""23","《医疗器械生产许可证》增加生产范围/增加生产产品","四川新奥洁医疗器械有限公司","91510000694839010N","冯彪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150054号","住所由成都市成华区新鸿南路86号25幢2楼变更为四川省成都市成华区新鸿南路86号25幢2楼;减少生产范围(2002年分类)Ⅱ类:6857-6-专用消毒设备;增加生产范围(2017年分类)Ⅱ类:11-03-化学消毒灭菌设备;产品延续注册后证号变更:麻醉机、呼吸机内部回路消毒机的注册证号由川械注准20162570022变更为川械注准20162110022.
","44148","44148","45692","四川省药品监督管理局""24","《医疗器械生产许可证》增加生产范围/增加生产产品","成都维雅诺义齿制作有限公司","91510132394598630Q","刘斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160050号","住所由新津县工业园A区希望路868号变更为成都市新津区工业园区A区希望路868号;生产地址文字性变更由成都新津县五津镇希望路868号2栋3单元2楼变更为成都新津区五津镇希望路868号2栋3单元2楼;产品延续注册后变更:定制式固定义齿的注册证号由川械注准20162630038变更为川械注准20162170038;定制式活动义齿的注册证号由川械注准20162630037变更为川械注准20162170037.
","44148","44148","44422","四川省药品监督管理局""25","《医疗器械生产许可证》延续","成都兰润生物科技有限公司","91510108693690592C","许兰君","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160031号","同意延续.
法定代表人为许兰君;企业负责人为王善明;住所为成都市成华区东三环路二段龙潭工业园;生产地址为成都市彭州市濛阳镇工业集中发展点物流大道西段468号22栋;生产范围为2002分类目录Ⅱ类:6866-4-导管、引流管2017分类目录Ⅱ类:14-15-病人护理防护用品;生产产品1鼻腔冲洗器川械注准201626600652海水鼻腔喷雾器川械注准20192140071","44148","44148","45973","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第31期)(截止2020.
11.
20)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》企业负责人变更","四川制药制剂有限公司","91510100777457202W","沈山","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200028号","企业负责人由梅圣亮变更为王强","44148","44148","45865","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","四川正美齿科科技有限公司","91512000MA691N2079","姚峻峰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190009号","受托生产产品定制式隐形正畸矫治器延续注册后,注册证号由浙械注准20152630787变更为浙械注准20152170787;受托生产日期从2020年10月21日延长到2023年8月15日.
","44152","44152","45312","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川君健万峰医疗器械有限责任公司","91510100095267188W","佟光敏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180029号","受托生产产品多功能失眠治疗仪(赣械注准20182090151)受托生产日期从2020年10月25日延长至2022年7月11日.
","44152","44152","45160","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","卡瓦(四川)医疗器械有限公司","91512000MA66NA1L43","侯刚","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190002号","增加生产范围(2017年分类)Ⅱ类:21-02-影像处理软件;增加生产产品数字化牙科影像处理软件(川械注准20202210198)和牙科影像存储与传输系统软件(川械注准20202210197).
","44153","44153","45298","四川省药品监督管理局""5","《医疗器械生产许可证》企业负责人变更","四川新德嘉伟医疗科技有限公司","91510185MA66F7FXXX","葛景霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200040号","企业负责人由徐潇变更王艳海","44151","44151","45955","四川省药品监督管理局""6","《医疗器械生产许可证》延续","四川阿尔泰医疗器械有限公司","91510681665385216T","黄永兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160025号","同意延续.
法定代表人为黄永兵;企业负责人为王加成;住所为四川省广汉市金鱼镇凉水井村九社;生产地址为广汉市金鱼镇凉水井村九社;生产范围为2002分类目录Ⅱ类:6810-8-矫形(骨科)外科用其它器械Ⅲ类:6846-1-植入器材2017分类目录Ⅱ类:04-17-脊柱外科辅助器械Ⅲ类:04-17-脊柱外科辅助器械,13-01-骨接合植入物,13-03-脊柱植入物;生产产品:1金属接骨螺钉国械注准201634618332空心接骨螺钉国械注准201734631113金属解剖型接骨板国械注准201734632604外固定支架川械注准201721002565金属直型接骨板国械注准201834610306椎体成形导向系统川械注准201820401577椎体扩张球囊导管国械注准201930401218金属锁定接骨螺钉国械注准201931302279金属锁定接骨板国械注准2019313037210交锁髓内钉国械注准2019313073311金属髓内针国械注准2020313021412脊柱内固定系统国械注准20153131023","44154","44154","45979","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","成都优途科技有限公司","915101005773691529","吴哲","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160046号","减少生产产品:全数字手持式超声诊断仪(MU1C型)(川械注准20162230146)和全数字手持式超声诊断仪(MU1L型)(川械注准20162230147).
","44154","44154","44405","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","四川恒明科技开发有限公司","915101067559967907","廖佳明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180003号","法定代表人由廖佳明变更为廖中华;产品延续注册后变更:经穴治疗仪的注册证号由川械注准20152270019变更为川械注准20152200019;手臂式全自动电子血压计的注册证号由川械注准20152200030变更为川械注准20152070030;手腕式全自动电子血压计的注册证号由川械注准20152200029变更为川械注准20152070029;减少生产范围(2002年分类)6820-2-血压计,6827-2-治疗仪器;增加生产范围(2017年分类)20-02-中医治疗设备.
","44154","44154","44947","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","四川阿斯特医疗器械有限公司","91510521588365739C","李允顺","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160015号","住所由四川省泸州市泸县城西工业园区C区金鹏路58号变更为四川省泸州市泸县城西工业园C区金鹏路58号;生产地址文字性变更由四川省泸州市泸县城西工业园区C区金鹏路58号3幢至8幢变更为四川省泸州市泸县城西工业园C区金鹏路58号3幢至8幢;增加生产范围(2017年分类)Ⅱ类:19-03-助行器械;产品延续注册后变更:手动轮椅车的注册证号由川械注准20152560155变更为川械注准20152190155.
","44154","44154","44277","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","爱齐(四川)医疗设备有限公司","91512000MA6AUMYR8R","JulieAnnColetti","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180023号","增加生产产品:口腔数字印模仪,川械注准20202170206.
","44154","44154","45118","四川省药品监督管理局""11","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","乙型肝炎病毒核心抗体IgM质控品(化学发光法)(注册证为国械注准20163401303)的产品名称变更为乙型肝炎病毒核心抗体IgM质控品.
","44155","44155","44067","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","产品延续注册后证号变更:一次性使用无菌手术单的注册证号由川械注准20152640161变更为川械注准20152140161;手术洞巾的注册证号由川械注准20152640162变更为川械注准20152140162;医用脱脂夹棉纱布块的注册证号由川械注准20162640033变更为川械注准20162140033;医用脱脂纱布的注册证号由川械注准20162640034变更为川械注准20162140034;医用脱脂纱布块的注册证号由川械注准20162640035变更为川械注准20162140035;增加生产产品:医用防护口罩川械注准20202140200;增加生产范围生产范围(2017年分类)Ⅱ类:14-09-不可吸收外科敷料.
","44155","44155","45614","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第32期)(截止2020.
11.
27)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","布法罗机器人科技(成都)有限公司","91510100MA61X6LL0B","程洪","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180043号","增加生产范围(2017年分类)Ⅱ类:19-02-运动康复训练器械;增加生产产品:减重步态训练器,川械注准20202190203.
","44158","44158","45244","四川省药品监督管理局""2","《医疗器械生产许可证》延续","成都新澳冠医疗器械有限公司","91510132564470307Y","曾义成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160030号","同意延续.
住所为四川新津工业园区兴园10路357号;生产地址为四川新津工业园区兴园10路357号6栋1-2层、7栋1层;法定代表人为曾义成;企业负责人为林燕;生产范围(2002年分类)Ⅱ类:6854-5-输液辅助装置,6866-4-导管、引流管;生产产品1无源压脉止血贴川械注准201625400232引流管固定器川械注准20172660002","44158","44158","45983","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第33期)(截止2020.
12.
14)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》核发","成都尚医信息科技有限公司","91510100394285773B","雷震","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200045号","新核发.
法定代表人为雷震;企业负责人为雷震;住所为中国(四川)自由贸易试验区成都高新区天府大道北段1700号1栋3单元17层1708号;生产地址为中国(四川)自由贸易试验区成都高新区天府大道北段1700号1栋3单元17层1708号;生产范围为2002分类目录Ⅱ类:6870-4-影象档案传输、处理系统软件2017分类目录Ⅱ类:21-06-其他;生产产品:运动测试与运动处方视频软件川械注准20202210188.
","44162","44162","45987","四川省药品监督管理局""2","《医疗器械生产许可证》法定代表人/企业负责人变更","四川金佳钲医疗器械有限公司","91510502MA622C046A","梁熙","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190027号","法定代表人由梁熙变更为刘兢兢;企业负责人由梁熙变更为刘兢兢.
","44162","44162","45461","四川省药品监督管理局""3","《医疗器械生产许可证》住所/生产地址文字性变更","四川科弘医疗器械有限公司","91510124057458813F","罗毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170003号","住所由郫县成都现代工业港北片区港通北三路589号变更为成都市郫都区成都现代工业港北片区港通北三路589号;生产地址文字性变更由郫县成都现代工业港北片区港通北三路589号F2、C1-2-3变更为成都市郫都区成都现代工业港北片区港通北三路589号F2、C1-2-3.
","44162","44162","44583","四川省药品监督管理局""4","《医疗器械生产许可证》企业名称变更","成都成电金盘健康数据技术有限公司","91510100709225442F","曲建明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180035号","企业名称由成都金盘电子科大多媒体技术有限公司变更为成都成电金盘健康数据技术有限公司.
","44162","44162","45197","四川省药品监督管理局""5","《医疗器械生产许可证》核发","佑华制药(乐山)有限公司","91511100MA6280126G","王志良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200046号","新核发.
法定代表人为王志良;企业负责人为王志良;住所为四川省乐山高新区临江北路2号;生产地址为四川省乐山高新区临江北路2号A栋、M栋、N栋建筑;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:Ⅱ类:14-14-医护人员防护用品;生产产品:一次性使用医用口罩,川械注准20202140209.
","44174","44174","45999","四川省药品监督管理局""6","《医疗器械生产许可证》核发","广元市众愿医疗科技有限公司","91510800MA62DTG1X6","母敏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200047号","新核发.
法定代表人为母敏;企业负责人为王培志;住所为四川省广元市经开区袁家坝仕农村医药园A区6号厂房三楼;生产地址为四川省广元市经开区袁家坝仕农村医药园A区6号厂房三楼;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:14-14-医护人员防护用品;生产产品:一次性使用医用口罩,川械注准20202140205.
","44174","44174","45999","四川省药品监督管理局""7","《医疗器械生产许可证》核发","雅安市康乐医疗器械有限责任公司","91511800779815333J","肖勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200048号","新核发.
法定代表人为肖勇;企业负责人为侯盛平;住所为雅安市雨城区南郊乡狮子村;生产地址为雅安市雨城区南郊乡狮子村8组;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品:一次性使用医用口罩,川械注准20202140212;医用外科口罩,川械注准20202140213.
","44174","44174","45999","四川省药品监督管理局""8","《医疗器械生产许可证》核发","四川省中药材医疗科技有限责任公司","91510681MA62R2HK4G","周进","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200049号","新核发.
法定代表人为周进;企业负责人为易学;住所为四川省德阳市广汉市北京大道一段16号;生产地址为四川省德阳市广汉市北京大道一段16号C1栋1楼;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品:一次性使用医用口罩,川械注准20202140201;医用外科口罩,川械注准20202140208.
","44174","44174","45999","四川省药品监督管理局""9","《医疗器械生产许可证》生产地址非文字性变更","成都联帮医疗科技股份有限公司","91510100633135511R","谢邦庆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150007号","生产地址非文字性变更由成都市双流区蛟龙工业港高新大道一座变更为成都市双流区蛟龙工业港高新大道一座、四川省成都蛟龙工业港双流园区南海大道四座(118号).
","44175","44175","45448","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","成都维信电子科大新技术有限公司","9151010062171126X9","陈志强","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149002号","产品延续注册后证号变更:氧气雾化面罩的注册证号由川械注准20162660066变更为川械注准20162080066.
","44175","44175","45442","四川省药品监督管理局""11","《医疗器械生产许可证》延续","成都威力生生物科技有限公司","91510100794916300L","陈贵文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160053号","同意延续.
法定代表人为陈贵文;企业负责人为陈贵文;住所为高新区科园南路88号天府生命科技园B6幢301;生产地址为高新区科园南路88号10栋3楼303、304号;生产范围为2002分类目录Ⅱ类:6845-8-血液透析用制水设备Ⅲ类:6845-4-血液净化设备和血液净化器具;2017分类目录Ⅱ类:10-03-血液净化及腹膜透析设备.
生产产品:1.
血液透析制水系统川械注准201724501612.
血液透析设备国械注准201734542723.
透析器复用机川械注准20162100080.
","44175","44175","46000","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","四川制药制剂有限公司","91510100777457202W","沈山","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200028号","增加生产产品:医用防护口罩,川械注准20202140220.
","44175","44175","45866","四川省药品监督管理局""13","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","增加生产产品:1、睾酮测定试剂盒(直接化学发光法),川械注准20202400210;2、雌二醇测定试剂盒(直接化学发光法),川械注准20202400211.
","44175","44175","45687","四川省药品监督管理局""14","《医疗器械生产许可证》延续","成都贝施美生物科技有限公司","915101120866763342","鄢新章","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160041号","同意延续.
法定代表人为鄢新章;企业负责人为鄢新章;住所为四川省成都经济技术开发区成龙路二段1666号;生产地址为四川省成都经济技术开发区成龙大道二段1666号B1栋1楼1号房、2楼1号房;生产范围为2002分类目录Ⅱ类:6863-7-金属、陶瓷类义齿材料;2017分类目录Ⅱ类:17-06-口腔义齿制作材料.
生产产品:1.
全瓷义齿用氧化锆瓷块及染色液川械注准201626300932.
牙科钛合金川械注准202021701503.
全瓷义齿用氧化锆彩色瓷块川械注准202021701494.
全瓷义齿用二硅酸锂玻璃陶瓷瓷块川械注准20202170148.
","44175","44175","46000","四川省药品监督管理局""15","《医疗器械生产许可证》增加生产范围/增加生产产品","四川维思达医疗器械有限公司","915105213269564325","周宗国","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190023号","增加生产产品:1、空心接骨螺钉,国械注准20203130887/2、直型金属接骨板,国械注准20203130792.
","44176","44176","45439","四川省药品监督管理局""16","《医疗器械生产许可证》增加生产范围/增加生产产品","成都思维多应用技术研究所","91510105746444329Q","李国成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190005号","产品延续注册后证号变更:自贴式热敷灵的注册证号由川械注准川食药监械(准)字2014第2260117号变更为川械注准20192090143.
","44176","44176","45307","四川省药品监督管理局""17","《医疗器械生产许可证》延续","四川微迪数字技术有限公司","91510100716092123A","钟茂","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160028号","同意延续.
法定代表人为钟茂;企业负责人为钟茂;住所为成都市锦江区滨江东路136号成都国际商务大厦B座10楼;生产地址为成都市锦江区滨江东路136号成都国际商务大厦B座10楼;生产范围为2002分类目录Ⅱ类:6821-8-电声诊断仪器,6846-5-器官辅助装置,6855-1-口腔综合治疗设备;2017分类目录Ⅱ类:07-05-电声学测量、分析设备.
生产产品:1.
耳鸣数字诊断治疗仪川械注准201722100542.
口吃矫正器川械注准201825500023.
听力计川械注准201722102204.
助听器川械注准201824600015.
耳鸣综合诊断治疗仪川械注准20152070025.
","44176","44176","46001","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第34期)(截止2020.
12.
18)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","成都博美医疗用品有限公司","91510122327500007E","章长林","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160038号","产品延续注册后证号变更:1、手术电极的注册证号由川械注准20162250081变更为川械注准20162010081;2、中性电极的注册证号由川械注准20162250084变更为川械注准20162010084;3、电刀清洁片的注册证号由川械注准20162250085变更为川械注准20162020085.
","44180","44180","45969","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都普什医药塑料包装有限公司","91510100785423440P","俞文骥","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150046号","增加生产产品:医用外科口罩,川械注准20202140218.
","44180","44180","45652","四川省药品监督管理局""3","《医疗器械生产许可证》延续","四川省遂宁市康达卫生材料有限公司","91510900708990468B","刘亚西","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160029号","同意延续.
法定代表人为刘亚西;企业负责人为刘亚西;住所为遂宁市创新工业园区南津南路14号;生产地址为遂宁市创新工业园区南津南路14号3栋;生产范围为2002年分类:Ⅱ类:6864-2-敷料、护创材料;2017年分类:Ⅱ类:14-09-不可吸收外科敷料,14-14-医护人员防护用品,14-16-其它器械.
生产产品:1.
脱脂棉纱布川械注准201826400802.
医用脱脂棉川械注准201826400813.
一次性使用医用口罩川械注准20202140140","44180","44180","46005","四川省药品监督管理局""4","《医疗器械生产许可证》延续","四川宇峰科技发展有限公司","91510700738312342X","吴庆扬","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160043号","同意延续.
法定代表人为吴庆扬;企业负责人为吴庆扬;住所为绵阳市经开区三江电子工业园;生产地址为绵阳市经开区板桥街68号10号厂房3楼A区、B区;生产范围为2002年分类:Ⅱ类:6823-1-超声诊断设备;2017年分类:Ⅱ类:07-03-生理参数分析测量设备.
生产产品:1.
彩色多普勒超声诊断系统川械注准201622300492.
动脉硬化检测仪川械注准20192070120","44180","44180","46005","四川省药品监督管理局""5","《医疗器械生产许可证》核发","成都牙贝美塑科技有限公司","91510107MA6DE1754A","潘毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200050号","新核发.
法定代表人为潘毅;企业负责人为钱岳;住所为成都市武侯区武青南路33号2栋507号、508号、525号、526号、527号、524号、103-2号;生产地址为成都市武侯区武青南路33号2栋507号、508号、525号、526号、527号、524号、103-2号;生产范围2002年分类:Ⅱ类:6863-10-正畸材料;2017年分类:Ⅱ类:17-07-口腔正畸材料及制品.
.
生产产品:保持器川械注准20202170196.
","44180","44180","46005","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","成都迈迪特科技有限公司","91510100394018894G","JACOBPIETERPAAUWE","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180012号","增加生产产品:超声膀胱容积测量仪,川械注准20202060207.
","44180","44180","45730","四川省药品监督管理局""7","《医疗器械生产许可证》延续","四川杏林医疗器械有限公司","91510521595090294H","童世兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160039号","同意延续.
法定代表人为童世兵;企业负责人为王堂汉;住所为四川省泸州市泸县玉蟾街道怡园路西段5号1-4幢;生产地址为泸县玉蟾街道怡园路西段5号1-4幢;生产范围为2002年分类:Ⅱ类::6864-2-敷料、护创材料;2017年分类:Ⅱ类:08-06-呼吸、麻醉用管路、面罩,14-13-手术室感染控制用品,14-14-医护人员防护用品.
生产产品:1.
一次性使用换药包川械注准201626401432.
一次性使用胃管川械注准201626601423.
医用脱脂棉纱布块川械注准201726402734.
一次性使用吸痰管川械注准201920801275.
一次性使用吸痰管包川械注准201920801286.
一次性使用鼻氧管川械注准201920801487.
一次性使用供氧吸痰管包川械注准201520800048.
一次性使用医用口罩川械注准202021401859.
医用外科口罩川械注准20202140186.
","44180","44180","46005","四川省药品监督管理局""8","《医疗器械生产许可证》企业负责人/住所变更","成都邦研科技有限公司","91510124098669350G","刘光友","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190050号","企业负责人由"刘光友"变更为"官鑫";住所由"成都市郫都区红光镇成都现代工业港北片区小微企业创新园长生桥路1111号"变更为"成都市郫都区成都现代工业港北片区小微企业创新园长生桥路1111号24栋".
","44181","44181","45563","四川省药品监督管理局""9","《医疗器械生产许可证》生产地址文字性变更","成都卓越义齿技术有限公司","91510122782668565G","刘晓","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160011号","生产地址文字性变更由"成都双流西南航空港经济开发区空港二路361号附327号、329号、331号"变更为"成都双流西南航空港经济开发区空港二路361号附327号2楼、329号1楼、2楼、331号2楼".
","44182","44182","45901","四川省药品监督管理局""10","《医疗器械生产许可证》延续","成都俊骋机电设备工程有限公司","91510100797831214P","鄢华","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160027号","同意延续.
法定代表人为鄢华;企业负责人为鄢华;住所为成都市锦江区东大街下东大街段216号1栋21层4号;生产地址为成都市龙泉驿区星光中路6号1层C区;生产范围为2002年分类:6854-6-负压吸引装置,6856-1-供氧系统;2017年分类:08-07-医用供气排气相关设备,14-06-与非血管内导管配套用体外器械.
生产产品:1.
医用中心供氧系统川械注准201920800952.
医用中心吸引系统川械注准20192140082.
","44183","44183","46008","四川省药品监督管理局""11","《医疗器械生产许可证》延续","奥泰医疗系统有限责任公司","91510100771215018D","雷旸","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160024号","同意延续.
法定代表人为雷旸;企业负责人为MarkXuemingZou;住所为四川省成都高新区(西区)天勤路201号;生产地址为四川省成都高新区(西区)天勤路201号;生产范围为2002年分类:Ⅱ类:6823-1-超声诊断设备,6830-2-医用X射线诊断设备Ⅲ类:6828-1-医用磁共振成像设备(MRI);2017年分类:Ⅱ类:06-01-诊断X射线机,06-07-超声影像诊断设备Ⅲ类:06-09-磁共振成像设备(MRI).
生产产品:1.
磁共振成像系统国械注准201532820312.
磁共振成像系统国械注准201732809813.
磁共振成像系统国械注准201832816194.
全数字彩色多普勒超声诊断系统川械注准201820601365.
磁共振成像系统国械注准201930604276.
乳腺磁共振成像系统国械注准202030601387.
数字化医用X射线摄影系统川械注准20202060090.
","44183","44183","46008","四川省药品监督管理局""12","《医疗器械生产许可证》延续","四川阿斯特医疗器械有限公司","91510521588365739C","李允顺","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160015号","同意延续.
法定代表人为李允顺;企业负责人为杨成贵;住所为四川省泸州市泸县城西工业园C区金鹏路58号;生产地址为四川省泸州市泸县城西工业园C区金鹏路58号3幢至8幢;生产范围为2002分类目录Ⅱ类:6856-2-病床;2017年分类:Ⅱ类:19-03-助行器械.
生产产品:1.
电动轮椅车川械注准201825601042.
手动轮椅车川械注准20152190155.
","44183","44183","46008","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第35期)(截止2020.
12.
25)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》延续","成都盛泰齿科技术有限公司","91510107677165472T","刘仁德","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160049号","同意延续.
法定代表人为刘仁德;企业负责人为刘述;住所为成都市双流区西航港开发区西航港大道中三段2667号;生产地址为成都市双流区西航港街道西航港大道中三段2667号1栋3层;生产范围为2002年分类:6863-16-定制式义齿;2017年分类:17-06-口腔义齿制作材料.
生产产品:1.
定制式固定义齿川械注准201726301822.
定制式活动义齿川械注准20172630183.
","44183","44183","46008","四川省药品监督管理局""2","《医疗器械生产许可证》企业负责人变更","成都派瑞义齿科技发展有限公司","9151011478011987XH","徐寿祥","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150060号","企业负责人由侯聃变更为刘旭.
","44186","44186","45746","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都昌华科技有限责任公司","91510100792152378M","陈昌标","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150010号","增加生产产品:1.
一次性使用医用口罩,川械注准20202140230;2.
医用外科口罩,川械注准20202140229.
","44186","44186","45454","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","绵阳立德电子股份有限公司","91510700717509138R","文云洋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许201150003号","增加生产产品:射频消融电极,川械注准20202010234.
","44186","44186","45503","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都维信电子科大新技术有限公司","9151010062171126X9","陈志强","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20149002号","产品延续注册后证号变更:尿流量监测仪的注册证号由川械注准20162210086变更为川械注准20162070086;增加2017年分类:Ⅱ类07-09-其他测量、分析设备智能尿流量监测仪产品名称变更为尿流量监测仪、高频电离子手术治疗仪产品名称变更为高频手术治疗仪.
","44186","44186","45442","四川省药品监督管理局""6","《医疗器械生产许可证》住所变更","成都利尼科医学技术发展有限公司","91510115669664933Q","王健","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200013号","住所由"成都市温江区成都海峡两岸科技产业开发园学府路"变更为"成都市温江区成都海峡两岸科技产业开发园青啤大道939号";生产地址文字性变更由"成都温江区成都海峡两岸科技产业开发园学府路"变更为"成都市温江区成都海峡两岸科技产业开发园青啤大道939号".
","44188","44188","45726","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川山岳生物科技有限公司","91512000MA666JH9XX","周文波","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190037号","增加生产产品:1、一次性使用医用口罩,川械注准20202140233;2、医用外科口罩,川械注准20202140232.
","44188","44188","45503","四川省药品监督管理局""8","《医疗器械生产许可证》增加生产范围/增加生产产品","四川阿尔泰医疗器械有限公司","91510681665385216T","黄永兵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160025号","增加生产产品:椎间融合器,国械注准20203130695.
","44188","44188","45979","四川省药品监督管理局""9","《医疗器械生产许可证》核发","四川省中兴药业有限公司","91510722752343305C","刘占兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200051号","新核发.
法定代表人为刘占兴;企业负责人为刘占兴;住所为三台县潼川镇上南街;生产地址为四川省绵阳市三台县青东坝工业集中区标准厂房二号楼一至二层、芦溪工业园区麦冬大健康产业园综合楼二楼;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品:一次性使用医用口罩(川械注准20202140236)、医用外科口罩(川械注准20202140235).
","44188","44188","46013","四川省药品监督管理局""10","《医疗器械生产许可证》核发","四川馨逸康医疗卫生用品有限责任公司","91511825MA68YXWG5U","李南波","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200052号","新核发.
法定代表人为李南波;企业负责人为李南波;住所为四川省天全县城厢镇安居北路333号;生产地址为四川省天全县城厢镇安居北路333号4栋,5栋B2105-B2110室,5栋B3106-B3109室;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品:一次性使用医用口罩(川械注准20202140222)、医用外科口罩(川械注准20202140223).
","44188","44188","46013","四川省药品监督管理局""11","《医疗器械生产许可证》增加生产范围/增加生产产品","成都贝施美生物科技有限公司","9.
15101120866763e+17","鄢新章","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160041号","产品延续注册后证号变更:全瓷义齿用氧化锆瓷块及染色液的注册证号由川械注准20162630093变更为川械注准20162170093.
","44188","44188","46000","四川省药品监督管理局""12","《医疗器械生产许可证》核发","成都艾养阳医学技术研究中心(有限合伙)","91510112MA6ADAJD2K","刘波(执行事务合伙人)","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200053号","新核发.
执行事务合伙人为刘波;企业负责人为刘波;住所为四川省成都经济技术开发区成龙大道二段1666号B2栋2层5号附1号;生产地址为四川省成都经济技术开发区成龙大道二段1666号B2栋2层5号附1号,6号;生产范围(2002年分类)Ⅱ类:6827-3-中医器具;生产范围(2017年分类)Ⅱ类:20-03-中医器具;生产产品:中药熏蒸治疗舱(川械注准20202200182).
","44189","44189","46014","四川省药品监督管理局""13","《医疗器械生产许可证》核发","成都凡米科技有限公司","91510100MA61T33A66","李卓东","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200054号","新核发.
法定代表人为李卓东;企业负责人为李卓东;住所为中国(四川)自由贸易试验区成都高新区世纪城南路599号5栋12层1203号;生产地址为中国(四川)自由贸易试验区成都高新区世纪城南路599号5栋12层1202号;生产范围(2002年分类)Ⅱ类:6820-1-体温计;生产范围(2017年分类)Ⅱ类:07-03-生理参数分析测量设备;生产产品:医用红外体温计(川械注准20202070227).
","44189","44189","46014","四川省药品监督管理局""14","《医疗器械生产许可证》增加生产范围/增加生产产品","成都贝施美生物科技有限公司","9.
15101120866763e+17","鄢新章","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160041号","产品延续注册后证号变更:全瓷义齿用氧化锆瓷块及染色液的注册证号由川械注准20162630093变更为川械注准20162170093.
","44189","44189","46000","四川省药品监督管理局""15","《医疗器械生产许可证》核发","四川利君精华生物科技有限公司","91510681MA62335Y4L","杨勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200055号","新核发.
法定代表人为杨勇;企业负责人为敬晓奎;住所为四川省德阳市广汉市三亚路三段188号3幢厂房;生产地址为四川省德阳市广汉市三亚路三段188号3幢B区、2车间A区、5号库C区;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:14-14-医护人员防护用品;生产产品:一次性使用医用口罩(川械注准20202140215).
","44189","44189","46014","四川省药品监督管理局""医疗器械生产许可信息通告(2020年第36期)(截止2020.
12.
31)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》核发","剑阁县成康医疗器械科技有限公司","91510823MA66G0MB03","胡进成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200056号","新核发.
法定代表人为胡进成;企业负责人为赵勇;住所为四川省广元市剑阁县下寺镇剑门工业园区四川成康动物药业有限公司3号厂房;生产地址为四川省广元市剑阁县下寺镇剑门工业园区四川成康动物药业有限公司3号厂房;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品:一次性使用医用口罩(川械注准20202140237)、医用外科口罩(川械注准20202140238).
","44193","44193","45653","四川省药品监督管理局""2","《医疗器械生产许可证》核发","四川宏盛昊医疗器械有限公司","91511702MA62R2TL98","吴倩","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200057号","新核发.
法定代表人为吴倩;企业负责人为邓洪川;住所为四川省达州市通川区农产品加工集中区标准厂房8幢四楼;生产地址为四川省达州市通川区农产品加工集中区标准厂房8幢四楼;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)Ⅱ类:14-14-医护人员防护用品;生产产品:一次性使用医用口罩(川械注准20202140219).
","44193","44193","45653","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川华柚医疗器械有限公司","91512000MA692RTY3H","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190051号","增加生产范围(2017年分类)Ⅱ类17-10-其他口腔材料;增加生产产品:脱敏剂(川械注准20202170123).
","44193","44193","45575","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","四川涑爽医疗用品有限公司","91512000MA64862P9W","肖丽娟","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200009号","增加生产产品:根管润滑剂,川械注准20202170202.
","44194","44194","45691","四川省药品监督管理局""5","《医疗器械生产许可证》核发","四川建玮高科技有限公司","91510107MA62N01D87","彭珏鸿","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200058号","新核发.
法定代表人为彭珏鸿;企业负责人为刘治君;住所为成都市成华区龙潭工业园成致路6号26栋3单元1-3层1号;生产地址为成都市成华区龙潭工业园成致路6号26栋3单元1-3层1号;生产范围(2002年分类)为Ⅱ类:6826-2-电疗仪器生产范围(2017年分类)为Ⅱ类:09-01-电疗设备/器具;生产产品:中频脉冲治疗仪为川械注准20202090241.
","44195","44195","46020","四川省药品监督管理局""6","《医疗器械生产许可证》核发","成都成信高科信息技术有限公司","915101220624398871","郑淑涵","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200059号","新核发.
住所为成都市双流西南航空港经济开发区工业集中区(西航港科技企业孵化园);生产地址为四川省成都市双流区西航港街道黄河中路二段388号7幢1单元11楼1105、1106、1108室;法定代表人为郑淑涵;企业负责人为李骥;生产范围(2002年分类)为Ⅱ类:6827-2-治疗仪器生产范围(2017年分类)为Ⅱ类:20-02-中医治疗设备;生产产品:电针治疗仪为川械注准20202200194.
","44195","44195","46020","四川省药品监督管理局""医疗器械生产许可信息通告(2021年第1期)(截止2021.
1.
8)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》核发","四川秀顿斯医疗器械有限公司","91512000MA6BBD0DX1","何国昆","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210001号","新核发.
住所为四川省资阳市现代大道3号C栋三层F1、F2、G1、G2区;生产地址为四川省资阳市现代大道3号C栋三层F1、F2、G1、G2区;法定代表人为何国昆;企业负责人为金成勋;生产范围(2002年分类)为Ⅲ类:6863-1-高分子义齿材料;(2017年分类)为Ⅱ类:17-06-口腔义齿制作材料.
生产产品:光固化临时冠桥树脂(川械注准20202170240).
","44200","44200","46025","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","奥泰医疗系统有限责任公司","91510100771215018D","雷旸","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160024号","产品延续注册后变更:磁共振成像系统的注册证号由国械注准20153282031变更为国械注准20153062031.
","44200","44200","46008","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","四川滋兴生物科技有限公司","91510923MA676T6L60","黄明英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200007号","1、增加生产范围/增加生产产品:增加2017年分类:14-13-手术室感染控制用品,14-14-医护人员防护用品;增加生产产品;一次性使用医用口罩(川械注准20202140224)、医用外科口罩(川械注准20202140225);2、生产地址非文字性变更:生产地址由"大英县工业集中发展区嘉创产业园17栋标准厂房二层生产车间"变更为"大英县工业集中发展区嘉创产业园17栋标准厂房一、二层生产车间";3、生产地址文字性变更由"大英县工业集中发展区嘉创产业园17栋标准厂房二层生产车间"变更为"大英县工业集中发展区嘉创产业园17栋标准厂房一、二层生产车间".
","44200","44200","45691","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","四川金科林医疗产业发展有限公司","91510115MA68YUPP6B","陈柏旭","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200044号","增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,增加生产产品:医用外科口罩,川械注准20202140248.
","44201","44201","45971","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都好特医疗器械有限公司","91510124597269845K","宋行","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160019号","增加生产范围2017年分类Ⅱ类:14-10-创面敷料,14-12-造口、疤痕护理用品,14-15-病人护理防护用品,18-01-妇产科手术器械;产品延续注册后变更:阴道填塞的注册证号由川械注准20152640175变更为川械注准20152180175;增加生产产品:一次性使用护脐带,川械注准20202140217;一次性医用水凝胶眼贴,川械注准20202140216;硅凝胶,川械注准20202140246;硅凝胶喷剂,川械注准20202140247.
","44201","44201","45969","四川省药品监督管理局""6","《医疗器械生产许可证》住所变更","成都牙贝美塑科技有限公司","91510107MA6DE1754A","潘毅","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200050号","住所由"成都市武侯区武青南路33号2栋507号、508号、525号、526号、527号、524号、103-2号"变更为"成都市武侯区武侯电商产业功能区管委会武青南路33号2栋507号、508号、525号、526号、527号、524号、103-2号";生产地址文字性变更由"成都市武侯区武青南路33号2栋507号、508号、525号、526号、527号、524号、103-2号"变更为"成都市武侯区武侯电商产业功能区管委会武青南路33号2栋507号、508号、525号、526号、527号、524号、103-2号".
","44202","44202","46005","四川省药品监督管理局""7","《医疗器械生产许可证》法定代表人/企业负责人","宜宾丽雅新材料有限责任公司","91511500MA69NFPCXE","张玉剑","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200036号","法定代表人由"邓传东"变更为"张玉剑";企业负责人由"贺敏"变更为"张玉剑".
","44203","44203","45929","四川省药品监督管理局""8","《医疗器械生产许可证》核发","成都彩虹集团新材料科技有限公司","'915101320574568776","黄朝万","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210002号","新核发.
住所为新津工业园区A区兴园十路;生产地址为成都市新津区新津工业园区A区兴园十路358号9号楼一楼、25号楼、5号楼三楼;法定代表人为黄朝万;企业负责人为李勇;生产范围(2002年分类)Ⅱ类:6864-2-敷料、护创材料;生产范围(2017年分类)为Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品:一次性使用医用口罩(川械注准20202140244);医用外科口罩(川械注准20202140243);医用防护口罩(川械注准20202140245).
","44204","44204","46029","四川省药品监督管理局""医疗器械生产许可信息通告(2021年第2期)(截止2021.
1.
15)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川康宁医用器材有限公司","91511126207506236U","朱良","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150055号","增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;产品延续注册后变更:一次性使用无菌注射针的注册证号由国械注准20153152174变更为国械注准20153142174;增加生产产品:一次性使用医用口罩,川械注准20202140253;医用外科口罩,川械注准20202140252.
","44207","44207","45627","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都迪康中科生物医学材料有限公司","915101007203615413","李晓萍","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150048号","增加生产范围(2017年分类)Ⅱ类:09-02-温热(冷)治疗设备/器具;增加生产产品:热敷贴,川械注准20202090226.
","44207","44207","45617","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都明森医疗器械有限责任公司","91510100743635584L","何德兴","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170011号","减少生产范围(2002年分类)Ⅱ类:6806-7-一次性使用口腔器械盒,增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品,14-15-病人护理防护用品,14-16-其它器械,17-02-口腔诊察器具;一次性使用无菌医用帽的注册证号由川械注准20162640057变更为川械注准20162140057;一次性使用无菌手术衣的注册证号由川械注准20162640060变更为川械注准20162140060;一次性使用无菌手术洞巾的注册证号由川械注准20162640059变更为川械注准20162140059;一次性使用口腔器械盒的注册证号由川械注准20162060025变更为川械注准20162170025;一次性使用治疗巾的注册证号由川械注准20162640026变更为川械注准20162140026;一次性使用医用单的注册证号由川械注准20162640028变更为川械注准20162140028;一次性使用护理垫的注册证号由川械注准20162640024变更为川械注准20162140024;复合碘医用消毒棉签的注册证号由川械注准20162640027变更为川械注准20162140027;一次性使用无菌医用口罩的产品名称变更为一次性使用医用口罩,注册证号由川械注准20162640058变更为川械注准20162140058.
","44207","44207","44642","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都新澳冠医疗器械有限公司","91510132564470307Y","曾义成","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160030号","减少生产范围(2002年分类)Ⅱ类:6854-5-输液辅助装置;增加生产范围(2017年分类)Ⅱ类:14-04-止血器具;产品延续注册后证号变更:无源压脉止血贴的注册证号由川械注准20162540023变更为川械注准20162140023.
","44207","44207","45983","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都博奥晶芯生物科技有限公司","91510115577375018L","高云","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150041号","增加生产范围(2017年分类)Ⅱ类:21-05-体外诊断类软件,增加生产产品:二十三项遗传性耳聋相关基因检测分析软件,川械注准20202210195.
","44209","44209","45601","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","四川君健万峰医疗器械有限责任公司","91510100095267188W","佟光敏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180029号","脉冲磁场刺激仪(注册证编号为川械注准20172210187)产品名称变更为磁场刺激仪.
","44209","44209","45160","四川省药品监督管理局""7","《医疗器械生产许可证》生产地址非文字性变更","成都普利泰生物科技有限公司","'915101003320359631","冉鹏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190014号","生产地址非文字性变更"成都高新区西区合作路333号1栋1层1号317-318,2栋1层1号一楼北区,2栋1层1号四楼北区"变更为"成都高新区西区合作路333号1栋1层1号317-318,2栋1层1号一楼,2栋1层1号四楼北区".
","44209","44209","45364","四川省药品监督管理局""8","《医疗器械生产许可证》延续","成都市新鸿牙科技术开发有限公司","91510122MA61T1D378","潘良才","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160036号","同意延续.
法定代表人为潘良才;企业负责人为潘良才;住所为成都市双流区西航港开发区西航港街道西航港大道中三段2667号;生产地址为成都市双流区西航港开发区西航港街道西航港大道中三段2667号1栋4层1室;生产范围为2002年分类:Ⅱ类:6863-16-定制式义齿.
生产产品:1.
定制式固定义齿川械注准201626301122.
定制式活动义齿川械注准20162630113.
","44209","44209","46034","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","四川恒明科技开发有限公司","915101067559967907","廖佳明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180003号","生产地址非文字性变更由四川省彭州工业开发区天彭镇旌旗西路39号4#、8#变更为四川省彭州工业开发区天彭镇旌旗西路39号3#、4#、8#;增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品;增加生产产品:医用外科口罩,川械注准20202140221.
","44209","44209","44947","四川省药品监督管理局""10","《医疗器械生产许可证》核发","四川省普诺思医疗科技有限公司","91510703MA65FLW99N","周茜","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210003号","新核发.
住所为四川省资阳市现代大道3号C栋三层F1、F2、G1、G2区;生产地址为四川省资阳市现代大道3号C栋三层F1、F2、G1、G2区;法定代表人为周茜;企业负责人为周茜;生产范围(2002年分类)为Ⅱ类:6863-16-定制式义齿;(2017年分类)为Ⅱ类:17-06-口腔义齿制作材料.
生产产品:1、定制式固定义齿(川械注准20212170007);2、定制式活动义齿(川械注准20212170006).
","44211","44211","46036","四川省药品监督管理局""11","《医疗器械生产许可证》核发","四川迅祺医疗科技有限公司","91510112MA698CXF5J","荣超","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210004号","新核发.
住所四川省成都经济技术开发区(龙泉驿区)成龙大道二段1666号B2栋4层4号;生产地址为四川省成都经济技术开发区(龙泉驿区)成龙大道二段1666号B2栋4层4号;法定代表人为荣超;企业负责人为李克伟;生产范围(2002年分类)为Ⅱ类:6820-1-体温计;(2017年分类)为Ⅱ类:Ⅱ类:07-03-生理参数分析测量设备.
生产产品:医用红外体温计(川械注准20202070251).
","44211","44211","46036","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","四川恒明科技开发有限公司","915101067559967907","廖佳明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180003号","生产地址非文字性变更由四川省彭州工业开发区天彭镇旌旗西路39号4#、8#变更为四川省彭州工业开发区天彭镇旌旗西路39号3#、4#、8#;增加生产范围(2017年分类)Ⅱ类:14-13-手术室感染控制用品;增加生产产品:医用外科口罩,川械注准20202140221.
","44209","44209","44947","四川省药品监督管理局""医疗器械生产许可信息通告(2021年第3期)(截止2021.
1.
22)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","四川恒明科技开发有限公司","915101067559967907","廖佳明","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180003号","增加生产范围(2017年分类)Ⅱ类:14-14-医护人员防护用品;增加生产产品:医用一次性防护服,川械注准20202140239.
","44214","44214","44947","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","四川拜阿蒙生物活性材料有限责任公司","91510100201990565A","朱向东","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150049号","增加生产范围(2017年分类)Ⅱ类:17-04-口腔治疗器具;增加生产产品:牙科种植专用器械包,川械注准20202170181.
","44214","44214","45753","四川省药品监督管理局""3","《医疗器械生产许可证》核发","四川迅祺医疗科技有限公司","91510112MA698CXF5J","荣超","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210004号","新核发.
法定代表人为荣超;企业负责人为李克伟;住所为四川省成都经济技术开发区(龙泉驿区)成龙大道二段1666号B2栋4层4号;生产地址为四川省成都经济技术开发区(龙泉驿区)成龙大道二段1666号B2栋4层4号;生产范围为2002分类目录Ⅱ类:6820-1-体温计2017分类目录Ⅱ类:07-03-生理参数分析测量设备;生产产品:医用红外体温计,川械注准20202070251.
","44211","44211","46036","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都仁爱义齿技术有限公司","915101005671905620","唐文喻","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160045号","增加生产范围(2017年分类)Ⅱ类:17-06-口腔义齿制作材料.
产品延续注册后变更:定制式固定义齿的注册证编号由川械注准20162630043变更为川械注准20162170043;定制式活动义齿的注册证编号由川械注准20162630042变更为川械注准20162170042.
","44214","44214","44405","四川省药品监督管理局""5","《医疗器械生产许可证》增加生产范围/增加生产产品","成都奇林科技有限责任公司","91510107723430952R","侯小青","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160048号","增加生产范围(2017年分类)Ⅲ类:05-03-放射治疗准直限束装置;产品延续注册后变更:自动多叶准直器的注册证编号由国食药监械(准)字2014第3221314号变更为国械注准20183051839;三维放射治疗计划系统【注册证编号为国食药监械(准)字2013第3701478号】延续注册后产品名称变更为三维放射治疗计划系统软件,证号变更为国械注准20173704092.
","44215","44215","44422","四川省药品监督管理局""6","《医疗器械生产许可证》增加生产范围/增加生产产品","瑞鹏医疗器械成都有限公司","91510132MA61RL0G4K","于辉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180031号","增加生产产品;柠檬酸消毒液(国械注准20203031003)","44215","44215","45174","四川省药品监督管理局""7","《医疗器械生产许可证》增加生产范围/增加生产产品","四川滋兴生物科技有限公司","91510923MA676T6L60","黄明英","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200007号","增加生产范围/增加生产产品:增加2017年分类:14-15-病人护理防护用品;增加生产产品;海水鼻腔喷雾器(川械注准20212140005);2、生产地址非文字性变更:生产地址由"大英县工业集中发展区嘉创产业园17栋标准厂房一、二层生产车间"变更为"大英县工业集中发展区嘉创产业园17栋标准厂房一、二、三层生产车间".
","44215","44215","45691","四川省药品监督管理局""8","《医疗器械生产许可证》核发","成都锦华药业有限责任公司","91510122202381139Y","郭敏","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210005号","新核发.
法定代表人为郭敏;企业负责人为张凡;住所为成都市双流区西航港大道中四段281号;生产地址为成都市双流区西航港大道中四段281号7栋C区、E区,5栋3楼;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品:1一次性使用医用口罩,川械注准20212140003;2医用外科口罩,川械注准20212140004.
","44216","44216","46041","四川省药品监督管理局""9","《医疗器械生产许可证》核发","四川省雨衣妹妹医疗器械有限公司","91510114MA69DMF7XR","刘仙","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210006号","新核发.
法定代表人为刘仙;企业负责人为刘仙;住所为四川省成都市新都区工业东区虎桥路199号;生产地址为四川省成都市新都区工业东区虎桥路199号C2栋;生产范围为2002分类目录Ⅱ类:6864-2-敷料、护创材料2017分类目录Ⅱ类:14-13-手术室感染控制用品,14-14-医护人员防护用品;生产产品1医用外科口罩,川械注准202121400092;一次性使用医用口罩,川械注准20212140010.
","44216","44216","46041","四川省药品监督管理局""10","《医疗器械生产许可证》增加生产范围/增加生产产品","成都邦研科技有限公司","91510124098669350G","刘光友","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20190050号","减少生产范围(2002年分类)Ⅱ类:6845-8-血液透析用制水设备,增加生产范围(2017年分类)Ⅱ类:11-05-清洗消毒设备.
减少生产产品:酸性氧化电位水生成器,川械注准20152570060;增加生产产品:酸性氧化电位水生成器,川械注准20202110145.
","44216","44216","45563","四川省药品监督管理局""医疗器械生产许可信息通告(2021年第4期)(截止2021.
1.
29)"序号","项目名称","行政相对人名称","行政相对人代码_1(统一社会信用代码)","法定代表人姓名","许可类别","许可证书名称","行政许可决定书文号","许可内容","许可决定日期","有效期自","有效期至","许可机关""1","《医疗器械生产许可证》增加生产范围/增加生产产品","成都艾科斯伦医疗科技有限公司","915101226988525032","夏斌","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150051号","增加生产产品:D-二聚体(D-Dimer)检测试剂盒(荧光免疫层析法),川械注准20202400204;抗缪勒氏管激素(AMH)检测试剂盒(荧光免疫层析法),川械注准20212400015;D-二聚体/纤维蛋白(原)降解产物(D-Dimer/FDP)质控品,川械注准20212400017;抗凝血酶Ⅲ(ATⅢ)质控品,川械注准20212400016.
","44221","44221","45691","四川省药品监督管理局""2","《医疗器械生产许可证》增加生产范围/增加生产产品","成都金典牙科技术开发有限公司","91510122080632592U","孙明力","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20180017号","增加生产范围(2017年分类)Ⅱ类:17-07-口腔正畸材料及制品.
增加生产产品:正畸矫治器,川械注准20212170011;正畸保持器,川械注准20212170012.
","44221","44221","45038","四川省药品监督管理局""3","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市新津事丰医疗器械有限公司","91510132202709202H","石保社","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150039号","产品延续注册后变更:一次性使用无菌注射针的注册证号由国械注准20163150109变更为国械注准20163140109.
","44221","44221","45614","四川省药品监督管理局""4","《医疗器械生产许可证》增加生产范围/增加生产产品","成都吉泰医疗器械有限公司","91510115551099932J","李雪松","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150062号","减少生产范围(2002年分类)Ⅱ类:6809-6-一次性使用管型痔吻合器;增加生产范围(2017年分类)Ⅱ类:14-10-创面敷料.
减少生产产品:一次性包皮环切缝合器,川械注准20162090055;增加生产产品:亲水性纤维敷料,川械注准20212140019.
","44221","44221","45627","四川省药品监督管理局""5","《医疗器械生产许可证》核发","绵阳川凡口腔科技有限公司","91510700MA62CA5W6U","芦安辉","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210007号","新核发.
法定代表人为芦安辉;企业负责人为芦安辉;住所为四川省绵阳市经开区塘汛镇塘坊大道677号积家工业园2栋2层C区;生产地址为四川省绵阳市经开区塘汛镇塘坊大道677号积家工业园2栋2层C区;生产范围2002分类目录Ⅱ类:6863-16-定制式义齿;2017分类目录Ⅱ类:17-06-口腔义齿制作材料;生产产品:1定制式固定义齿,川械注准20212170013;2定制式活动义齿,川械注准20212170014.
","44221","44221","46046","四川省药品监督管理局""6","《医疗器械生产许可证》延续","成都优途科技有限公司","915101005773691529","吴哲","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160046号","同意延续.
住所为成都高新区科技孵化园8号楼03层04号;生产地址为成都高新区科技孵化园8号楼03层10号;法定代表人为吴哲;企业负责人为吴哲;生产范围(2002年分类)Ⅱ类:6823-1-超声诊断设备;生产范围(2017年分类)Ⅱ类:06-07-超声影像诊断设备;生产产品1全数字手持式彩色超声诊断仪川械注准201722302802全数字手持式彩色超声诊断仪川械注准201722302813全数字便携式彩色超声诊断仪川械注准201722302824全数字便携式彩色超声诊断仪川械注准201820601795全数字便携式彩色超声诊断仪川械注准20182060178","44221","44221","46046","四川省药品监督管理局""7","《医疗器械生产许可证》延续","广安市欣诺德义齿技术发展有限公司","91511602MA62B0HF04","罗克琼","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160037号","同意延续.
住所为广安市广安区兴隆街22号1单元202室;生产地址为广安市广安区兴隆街22号1单元202室;法定代表人为罗克琼;企业负责人为罗克琼;生产范围(2002年分类)为Ⅱ类:6863-16-定制式义齿生产产品1为定制式固定义齿为川械注准20162630063为2为定制式活动义齿为川械注准20162630064.
","44221","44221","46046","四川省药品监督管理局""8","《医疗器械生产许可证》生产地址非文字性变更","成都百裕玛仕柯医疗用品制造有限公司","91510115MA68YPKKXT","高志文","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200033号","生产地址非文字性变更由成都市温江区成都海峡两岸科技产业开发园柳台大道西段433号A12变更为成都市温江区成都海峡两岸科技产业开发园柳台大道西段433号A12;成都市温江区安贤路433号A03栋2~3层.
","44221","44221","45921","四川省药品监督管理局""9","《医疗器械生产许可证》增加生产范围/增加生产产品","成都市萨尼医疗器械有限公司","91510100395770519K","何春霞","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170020号","增加生产产品:机用根管器械,川械注准20212170020.
","44221","44221","44737","四川省药品监督管理局""10","《医疗器械生产许可证》注销","内江市科源医疗设备有限责任公司","91511000206440503G","邹佑铭","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160040号","同意注销.
","44221","44221","44388","四川省药品监督管理局""11","《医疗器械生产许可证》增加生产范围/增加生产产品","迈克生物股份有限公司","9151000020186004X7","唐勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20150064号","减少生产产品:天门冬氨酸氨基转移酶测定试剂盒(天门冬氨酸底物法),川械注准20152400182总胆固醇测定试剂盒(CHOD-PAP法),川械注准20152400184;葡萄糖测定试剂盒(己糖激酶法),川械注准20152400187;碱性磷酸酶测定试剂盒(NPP底物-AMP缓冲液法),川械注准20152400179;α-淀粉酶测定试剂盒(EPS底物法),川械注准20152400180;超敏C-反应蛋白测定试剂盒(胶乳增强免疫透射比浊法),川械注准20152400181;直接胆红素测定试剂盒(钒酸盐氧化法),川械注准20152400183;尿素测定试剂盒(尿素酶-谷氨酸脱氢酶法),川械注准20152400186;增加生产产品:抗凝血酶Ⅲ测定试剂盒(发色底物法),川械注准20202400214;胰岛素测定试剂盒(直接化学发光法),川械注准20212400001;C肽测定试剂盒(直接化学发光法),川械注准20212400002;游离脂肪酸测定试剂盒(ACS-ACOD法),川械注准20212400018;凝血质控血浆,川械注准20212400023;凝血校准血浆,川械注准20212400024;铁测定试剂盒(亚铁嗪法),川械注准20212400025;铜测定试剂盒(PAESA显色剂法),川械注准20212400026;抗缪勒氏管激素测定试剂盒(直接化学发光法),川械注准20212400027;抗缪勒氏管激素质控品,川械注准20212400028;超敏C-反应蛋白测定试剂盒(免疫散射比浊法),川械注准20212400029;全段甲状旁腺激素测定试剂盒(直接化学发光法),川械注准20212400030.
","44223","44223","45687","四川省药品监督管理局""12","《医疗器械生产许可证》增加生产范围/增加生产产品","四川普瑞斯生物科技有限公司","91511503563252148F","雷冰","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20170033号","增加生产产品:一次性使用精密过滤袋式输液器带针(国械注准20203141009)和一次性使用精密过滤输液器带针(国械注准20203140960).
","44223","44223","44824","四川省药品监督管理局""13","《医疗器械生产许可证》增加生产范围/增加生产产品","雅安市康乐医疗器械有限责任公司","91511800779815333J","肖勇","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20200048号","增加生产范围(2017年分类)Ⅱ类:14-16-其它器械,增加生产产品:医用无菌棉签,川械注准20212140032.
","44225","44225","45999","四川省药品监督管理局""14","《医疗器械生产许可证》延续","成都皓峰齿科技术有限责任公司","91510122MA61TKN59M","陈锋","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20160035号","同意延续.
住所为成都市双流区西航港开发区西航港大道中三段2635号;生产地址为成都市双流区西航港开发区西航港大道中三段2635号办公楼1楼101、2楼202;法定代表人为陈锋;企业负责人为陈锋;生产范围(2002年分类)为Ⅱ类:6863-16-定制式义齿;生产产品:1定制式固定义齿川械注准201626301052定制式活动义齿川械注准20162630106.
","44225","44225","46050","四川省药品监督管理局""15","《医疗器械生产许可证》核发","四川互慧软件有限公司","91510700MA624CD23M","张维","普通","《医疗器械生产许可证》(含生产产品登记表)","川食药监械生产许20210008号","新核发.
新核发.
法定代表人为张维;企业负责人为黄平;住所为绵阳科创区创新中心3号楼117室;生产地址为绵阳市科创区创新中心二期3号楼1楼109室、110室;生产范围为2002分类目录Ⅱ类:6870-4-影象档案传输、处理系统软件;2017分类目录Ⅱ类:21-02-影像处理软件;生产产品:医学影像存档与通讯系统管理软件,川械注准20202210242.
","44225","44225","46050","四川省药品监督管理局"