医疗器械法规、注册、临床、体系认证、信息系统一站式服务
24×7服务热线:0571-86198618 简体中文 ENGLISH
当前位置:网站首页>关于我们>新闻动态
2021年12月进口第一类医疗器械产品备案信息
发布日期:2022-01-13 00:00浏览次数:674次
2022年1月11日,药监总局发布《2021年12月进口第一类医疗器械产品备案信息》公告,2021年最后一个月药监总局完成医用丝绸胶带、医用检查手套等156个尽快医疗器械产品备案项目审批。

2022年1月11日,药监总局发布《2021年12月进口第一类医疗器械产品备案信息》公告,2021年最后一个月药监总局完成医用丝绸胶带、医用检查手套等156个尽快医疗器械产品备案项目审批。

产品名称备案号备案人名称原文生产地址原文备案日期状态
医用丝绸胶带国械备20210631号Paul   Hartmann AGP.   I. Pla d'en Boet II, c/ Carrasco i Formiguera, 48, 08302 Mataró (Barcelona),   SPAIN2021-12-31 有效
牙骨锤国械备20200356号//2021-12-31 变更
基台就位器国械备20210042号//2021-12-31 变更
种植体系统工具国械备20140102号/959-21,Dae   Chon-dong,Buk-gu,Gwangju2021-12-31 变更
创口贴国械备20181401号東洋化学株式会社滋賀県蒲生郡日野町寺尻1008番地2021-12-31 变更
牙科用剪国械备20200357号//2021-12-31 变更
创口贴国械备20181400号東洋化学株式会社滋賀県蒲生郡日野町寺尻1008番地2021-12-31 变更
动力系统配套工具国械备20210630号 Synthes GmbHEimattstrasse   3, 4436 Oberdorf, Switzerland2021-12-31 有效
动脉瘤夹钳国械备20210629号Aesculap   AGAm   Aesculap-Platz, 78532 Tuttlingen, Germany2021-12-31 有效
定位环国械备20200262号//2021-12-30 变更
医用检查手套国械备20210628号Ara?onesa   de ExportaciónInternacional 24 S.L.AVDA.   DE LOS TRABAJADORES, 13, 03430 ONIL (ALICANTE)2021-12-30 有效
肩关节手术工具国械备20180880号Zimmer   Inc.1800W.   Center Street Warsaw Indiana 46580 USA2021-12-30 变更
耳鼻喉科用测量器国械备20210627号Grace   Medical, Inc.8500   Wolf Lake Drive, Suite 110 Memphis, Tennessee 38133, USA2021-12-30 有效
血细胞分析用染色液国械备20210626号Siemens   Healthcare Diagnostics Inc.Parc   Euromédecine, Rue du Caducée, BP 7290, Montpellier Cedex 4, 34184 France2021-12-30 有效
造口袋国械备20181323号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2021-12-30 变更
防漏膏国械备20190264号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2021-12-30 变更
固定器械包国械备20210625号Becker   Orthopedic Appliance Co.635   Executive Drive, Troy, Michigan, 48083, United States2021-12-30 有效
造口袋国械备20210169号ConvaTec   LimitedCarretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2021-12-30 变更
截断刀国械备20210624号Grace   Medical, Inc.8500   Wolf Lake Drive, Suite 110 Memphis, Tennessee 38133, USA2021-12-29 有效
脊柱手术工具包国械备20210623号AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-12-29 有效
脊柱手术工具包国械备20210622号AESCULAP   AGAm   Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-12-29 有效
医用纸质胶带国械备20210621号Paul   Hartmann AGP.   I. Pla d'en Boet II, c/ Carrasco i Formiguera, 48, 08302 Mataró (Barcelona),   SPAIN2021-12-29 有效
全自动血沉分析仪国械备20210620号Greiner   Bio-One GmbHVan   Rensselaerweg 4, 6956 AV Spankeren, The Netherlands2021-12-28 有效
牙科工具国械备20170151号MOZO-GRAU,   S.A.C/Santiago   López González, 7, 47197, Valladolid, Spain2021-12-28 变更
软组织环切刀国械备20160054号MOZO   GRAU, S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 变更
牙科种植定位器国械备20160447号MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 变更
转移帽国械备20160448号MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 变更
牙用尺国械备20160446号MOZO   GRAU,S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 变更
牙科种植工具国械备20160057号MOZO   GRAU, S.A.C/Santiago   Lopez Gonzalez, 7, 47197, VALLADOLID, Spain2021-12-28 变更
牙科工具国械备20190327号MOZO-GRAU,   S.A.C/Santiago   López González, 7, 47197 Valladolid. Spain2021-12-28 变更
牙科工具国械备20200153号MOZO-GRAU,   S.A.C/   SANTIAGO LóPEZ GONZáLEZ 7 - 47197 VALLADOLID SPAIN2021-12-28 变更
颈椎前路固定板系统手术工具国械备20170832号Bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2021-12-28 变更
固定用弹力束带国械备20181484号Bauerfeind   AGTriebeser   Straβe 16 07937 Zeulenroda- Triebes Germany2021-12-28 变更
缓冲液国械备20161681号Helena   Biosciences EuropeQueensway   South,Team Valley Trading Estate,Gateshead,Tyne and Wear,NE11 0SD,United   Kingdom2021-12-27 变更
缓冲液国械备20190186号Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-27 变更
外科手术固定器械国械备20210619号Berchtold   GmbH & Co. KGLudwigstaler   Stra?e 25, 78532 Tuttlingen, Germany2021-12-27 有效
全自动样本处理系统国械备20151954号Beckman   Coulter, Inc.Sauerbruchstr.   50, 81377, Muenchen, Germany2021-12-27 变更
染色机 国械备20151321号Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2021-12-27 变更
一次性使用取样器国械备20210196号Novosanis   NVBijkhoevelaan   32c, 2110 Wijnegem, Belgium2021-12-27 变更
瓣膜成形环测环器及组件国械备20160017号Corcym   S.r.l.Via   Crescentino sn 13040 SALUGGIA (VC) ITALY2021-12-24 变更
样本稀释液国械备20190227号Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-23 变更
清洗液国械备20161594号Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-23 变更
髋关节手术器械国械备20200250号Brainlab   AGOlof-Palme-Stra?e   9, 81829 München, Germany2021-12-23 变更
种植用手术导板国械备20170395号FIMS   Co., Ltd.B1,   440 Changnyong-daero, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea Rep.2021-12-23 变更
口腔科手术工具包国械备20170494号FIMS   Co., Ltd.B1,   440 Changnyong-daero, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea Rep.2021-12-23 变更
电动移位机国械备20200573号ArjoHuntleigh   ABul.ks.Wawrzyniaka   2, 62-052 Komorniki, Poland2021-12-23 变更
慢性淋巴细胞白血病染色体及基因异常检测试剂盒(原位杂交法)国械备20181122号Abbott   Molecular Inc.1300   East Touhy Avenue, Des Plaines, IL 60018, USA2021-12-23 变更
骨髓增生异常综合征染色体及基因异常检测试剂盒(原位杂交法)国械备20181112号Abbott   Molecular Inc.1300   East Touhy Avenue, Des Plaines, IL 60018, USA2021-12-23 变更
骨髓增生异常综合征染色体及基因异常检测试剂盒(原位杂交法)国械备20181121号Abbott   Molecular Inc.1300   East Touhy Avenue, Des Plaines, IL 60018, USA2021-12-23 变更
CD56检测试剂国械备20210618号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56检测试剂国械备20210617号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56检测试剂国械备20210616号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD45检测试剂国械备20210615号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD45检测试剂国械备20210614号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
CD56检测试剂国械备20210613号BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-12-22 有效
视力表投影仪国械备20210612号株式会社ニデック日本愛知県額田郡幸田町大字久保田字社口7番地2021-12-22 有效
采血笔国械备20160424号Roche   Diabetes Care GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2021-12-22 变更
造口皮肤保护剂国械备20210611号康维德有限责任公司ConvaTec   LimitedUnit   12A&12B Kings Court,Prince William Avenue,Sandycroft,Deeside,CH5 2FG,   United Kingdom2021-12-22 有效
医用外固定支具国械备20210610号opcnM   inc.413,Exporo,Yusung-gu,Daejeon-si,Korea2021-12-22 有效
血细胞分析用染色液国械备20210609号SYSMEX   CORPORATION17   Takumidai,Ono,Hyogo 675-1322,Japan2021-12-21 有效
尿液分析用染色液国械备20210608号SYSMEX   CORPORATION17   Takumidai,Ono,Hyogo 675-1322,Japan2021-12-21 有效
医用体位胶垫国械备20170691号M?lnlycke   Health Care AB3902   Hanna Cir Suites A, E & F Indianapolis,IN 462412021-12-21 变更
引流袋国械备20190792号Medela   AGL?ttichstrasse   4b 6341 Baar SWITZERLAND2021-12-20 变更
全自动毛细管电泳仪国械备20160005号Helena   Biosciences EuropeSunderland   Enterprise Park Colima Avenue Sunderland SR5 3XB United Kingdom2021-12-20 变更
穴位压力刺激贴国械备20210607号和光電研株式会社大阪府八尾市太田新町1丁目33番地2021-12-20 有效
成形片国械备20180652号Polydentia   SAVia   Cantonale 47,CH-6805 Mezzovico2021-12-20 变更
牙科手术器械包国械备20181728号Polydentia   SAVia   Cantonale 47, CH-6805 Mezzovico2021-12-20 变更
口腔科手术器械国械备20210606号Asim   InstrumentsAir   Port Road Gohadpur Sialkot Pakistan2021-12-17 有效
创口贴国械备20190697号LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2021-12-16 变更
缓冲液国械备20190540号Helena   Biosciences EuropeQueensway   South Team Valley Trading Estate Gateshead Tyne and Wear NE11 0SD United   Kingdom2021-12-16 变更
缓冲液国械备20190136号Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2021-12-16 变更
医用脱敏胶布带国械备20210605号Paul   Hartmann AGP.   I. Pla d'en Boet II, c/ Carrasco i Formiguera, 48, 08302 Mataró (Barcelona),   SPAIN2021-12-16 有效
一次性粪便蛋白提取装置国械备20210604号INOVA   Diagnostics, Inc.VIA   FLAVIA 122 TRIESTE, Trieste ITALY 341472021-12-16 有效
蛋白提取试剂国械备20210603号INOVA   Diagnostics, Inc.9900   Old Grove Road San Diego California 92131 USA2021-12-16 有效
倒像镜及装置 国械备20180442号OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar,Germany2021-12-16 变更
一次性使用末梢采血管国械备20210045号SARSTEDT   AG & Co. KGWinterborner   Stra?e,D-51588 Nümbrecht-Winterborn2021-12-15 变更
膜提升水管国械备20210602号Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu,Busan,Korea2021-12-15 有效
口腔科用CT检查杆国械备20210601号Osstem   Implant Co., Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2021-12-15 有效
CD8检测试剂国械备20180807号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD3检测试剂国械备20180800号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
血细胞分析用溶血剂国械备20140201号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
HLA-DR检测试剂国械备20180791号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD8检测试剂国械备20180729号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD7检测试剂国械备20180789号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD5检测试剂国械备20180799号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD4检测试剂国械备20180795号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD4检测试剂国械备20180727号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD8检测试剂国械备20180787号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD13检测试剂国械备20180804号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD45RA检测试剂国械备20180786号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD8检测试剂国械备20180796号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD45RO检测试剂国械备20180793号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD45检测试剂国械备20180797号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD45检测试剂国械备20180794号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD45检测试剂国械备20180788号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
CD25检测试剂国械备20180805号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2021-12-15 变更
牙科成形片及配套工具国械备20152003号DENTSPLY   Caulk38   West Clarke Avenue Milford, DE 19963 USA2021-12-15 变更
透析用废液袋国械备20210600号Gambro   Dasco S.p.A Medolla Facility Stegne   11 Ljubljana 1000 Slovenia2021-12-14 有效
牙科种植工具国械备20191423号Cybermed,Inc.6-26,   Yuseong-daero 1205beon-gil, Yuseong-gu, Daejeon 34104 Republic of Korea2021-12-14 变更
MSH6抗体试剂(免疫组织化学)国械备20210599号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2021-12-14 有效
动力系统配套工具国械备20210407号The   Anspach Effort, Inc4500   Riverside Drive,Palm Beach Gardens,FL 334102021-12-14 变更
医用退热贴 国械备20190981号東和製藥株式会社和歌山県紀の川市貴志川町丸栖1229番地2021-12-13 变更
牙科种植工具包国械备20210598号Nanoden204,   88, Somang-gil, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, Republic of Korea   ; 1-101, 32, Gongam-gil, Sangbuk-myeon, Yangsan-si, Gyeongsangnam-do,   Republic of Korea2021-12-10 有效
牙科刮治器国械备20210597号PRODONT-HOLLIGER   SOCIETE PAR ACTIONSLieu-dit   La Marnasse,63880 OLLIERGUES,France2021-12-10 有效
样本稀释液国械备20210596号富士レビオ株式会社日本国東京都八王子市小宮町51番地2021-12-10 有效
CDX-2抗体试剂(免疫组织化学)国械备20210595号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2021-12-09 有效
GATA3抗体试剂(免疫组织化学)国械备20210594号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2021-12-09 有效
牙科手术器械国械备20210593号ZARYAB   INSTRUMENTSMohallah   Pir Sabz Harar, Wazirabad Road, Sialkot - 51310 - Pakistan2021-12-09 有效
全自动电泳仪国械备20140222号Helena   Laboratories1530   Lindbergh Dr. P.o. Box 752 Beaumont, TX 777042021-12-09 变更
全自动电泳仪国械备20151816号HELENA   LABORATORIES1530   Lindbergh Dr. P.o. Box 752 Beaumont, TX 777042021-12-09 变更
膝关节手术工具国械备20210592号DePuy   (Ireland)68   Mill Lane Road, Brimfield MA 01010, USA; 2122 Winners Circle, Dayton, Ohio   45404 USA2021-12-09 有效
髋关节拉钩国械备20210591号Accuratus   AGHolligenstrasse   94, CH-3008 Bern2021-12-09 有效
口腔治疗器具国械备20210590号REFINE   SURGICAL (PVT) LTD.Near   Pasrur Bypass Stop,Sialkot Road,Dsaka,Distt,Sialkot-Pakistan2021-12-09 有效
医用检查手套国械备20180958号O&M   Halyard, Inc.No.   200 Moo 8, Kanchanavanich Rd., Tambol Prik, Sadao, Songkhla, 90120, Thailand2021-12-08 变更
牙科抛光磨头国械备20210589号株式会社松風京都府久世郡久御山町市田新珠城21番地12021-12-08 有效
瑞氏-吉姆萨染色液 国械备20210588号RAL   DIAGNOSTICSSite   Montesquieu, 33650 MARTILLAC , FRANCE2021-12-07 有效
医用检查手套国械备20210587号SGMP   Company Limited181   Moo 6 Tambol, Kampaengphet, Amphur Rattaphum, Songkhla, 90180 Thailand.2021-12-07 有效
PMS2抗体试剂(免疫组织化学)国械备20210586号 Leica Biosystems Newcastle Ltd Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2021-12-07 有效
p16抗体试剂(免疫组织化学)国械备20210585号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2021-12-07 有效
全自动电泳仪 国械备20160748号HELENA   LABORATORIES, CORP.1530   Lindbergh Dr. P.o. box 752 Beaumont, TX 777042021-12-06 变更
MSH2抗体试剂(免疫组织化学)国械备20210584号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2021-12-06 有效
MLH1抗体试剂(免疫组织化学)国械备20210583号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2021-12-06 有效
弹力绷带国械备20210582号Bort   GmbH/2021-12-06 有效
眼底广角观察镜国械备20210581号OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar, Germany2021-12-06 有效
基础外科手术器械国械备20210580号UAMED   SURGICAL INDUSTRIESMohallah   Ghari,Bhopalwala Tehsil Sambrial District Sialkot Pakistan2021-12-03 有效
种植体扫描体国械备20180613号MegaGen   Implant Co.,Ltd.MegaGen   Implant, 472, Hanjanggun-ro, Jain-myeon,Gyeongsan-si, Gyeongsangbuk-do2021-12-03 变更
轮转式切片机国械备20160787号pfm   medical agWankelstraβe   60  50996 K?ln, Germany2021-12-03 变更
轮转式切片机国械备20160786号pfm   medical agWankelstraβe   60  50996 K?ln, Germany2021-12-03 变更
包埋机国械备20190921号pfm   medical agWankelstra?e   60, 50996 K?ln, Germany2021-12-03 变更
轮转式切片机国械备20160789号pfm   medical agWankelstraβe   60  50996 K?ln, Germany2021-12-03 变更
负压引流器国械备20170221号pfm   medical mepro gmbhAm   S?terberg 4, 66620 Nonnweiler-Otzenhausen, Germany2021-12-03 变更
轮转式切片机国械备20200279号pfm   medical agWankelstr.   60, 50996 K?ln, Germany2021-12-03 变更
核酸提取或纯化试剂国械备20160133号Roche   Diagnostics GmbHNonnenwald   2, 82377 Penzberg, Germany2021-12-03 变更
创口贴国械备20190644号LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2021-12-03 变更
创口贴国械备20190699号LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2021-12-03 变更
创口贴国械备20190713号LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2021-12-03 变更
核酸提取试剂国械备20210579号台灣圓點奈米技術股份有限公司桃園市桃園區龍山里龍壽街   81 巷 12 弄 2 號2021-12-03 有效
腕关节固定器国械备20210578号3M   Company3M   EDUMEX, S.A DE C.V 6620 ORIENTE CALLE RAMON RIVERA LARA CD. JUAREZ,   Chihuahua, MEXICO 326052021-12-03 有效
创口贴国械备20190645号LABORATOIRE   HRA PHARMAColoplast   utca2,4300 Nyírbátor, Hungary 2021-12-03 变更
核酸提取试剂国械备20210577号台灣圓點奈米技術股份有限公司桃園市桃園區龍山里龍壽街   81 巷 12 弄 2 號2021-12-03 有效
造口袋国械备20181323号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 qarque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2021-12-03 变更
医用弹力贴布国械备20210576号Aktimed   GmbHPol.Ind.   Santa Anna C/ Vilella de Claret, 6, 08272 Sant Fruitós de Bages (Barcelona)2021-12-03 有效
MSH2抗体试剂(免疫组织化学)国械备20190562号BOND   Ready-to-Use Primary Antibody MSH2 (Mismatch Repair Protein) (25D12)Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2021-12-03 无效
MLH1抗体试剂(免疫组织化学)国械备20190567号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2021-12-03 无效
骨科手术器械包国械备20171005号SPINEWAY7   Allee Moulin Berger,69130 ECULLY, France2021-12-02 变更
骨科手术器械包国械备20180241号SPINEWAY7   Allee Moulin Berger,69130 ECULLY, France2021-12-02 变更
Calretinin抗体试剂(免疫组织化学)国械备20210575号Biocare   Medical,LLC60   Berry Drive Pacheco,CA 94553 2021-12-02 有效
Calponin抗体试剂(免疫组织化学)国械备20210574号Biocare   Medical,LLC60   Berry Drive Pacheco,CA 94553 2021-12-02 有效
CD34抗体试剂(免疫组织化学)国械备20210573号Biocare   Medical,LLC60   Berry Drive Pacheco,CA 94553 2021-12-02 有效
医用冷敷贴国械备20210572号英屬維京群島商凱富企業股份有限公司台灣分公司屏東縣屏東市清溪里和生路三段1006號2021-12-02 有效
液基超薄层细胞自动涂片机国械备20210571号ILSA   SARL16   rue de la Comtesse, 25640 Marchaux, France2021-12-02 有效
牙科种植手术用器械包国械备20180124号台灣植體科技股份有限公司高科分公司高雄市路竹區路科二路63號5樓2021-12-02 变更
打磨抛光组件国械备20210570号TOP   BM7a,   bld. 2, apt. 44b, Novatorov str., Moscow, 119421, Russia2021-12-01 有效
成形片国械备20210569号TOP   BM7a,bld.2,apt.44b,Novatorov   str.,Moscow,119421,Russia2021-12-01 有效
造口皮肤保护剂国械备20210568号康维德有限责任公司ConvaTec   LimitedHickmans   Road, Birkenhead, Wirral CH41 1JH United Kingdom2021-12-01 有效
造口袋国械备20210567号 B. Braun Medical SAS Z.l.de   Layats, 64500 Saint-Jean-de-Luz, FRANCE; 13 rue Croix la Comtesse, 28400   Nogent-le-Rotrou, FRANCE 2021-12-01 有效

任何有关j进口第一类医疗器械产品备案需求,欢迎您随时方便与杭州证标客联络。

Copyright © 2018 医疗器械注册技术咨询 浙ICP备18025678号 技术支持:熙和网络

新闻动态