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2026年10月【进口第一类医疗器械产品备案】信息
发布日期:2026-11-12 00:00浏览次数:27次
来自国家药监局2026年11月11日公开披露的消息，2026年10月国家药监局累计批准130项进口第一类医疗器械产品备案事项，其中，进口第一类医疗器械首次备案25项；进口第一类医疗器械变更备案102项；进口第一类医疗器械取消备案3项，一起来看具体内容。

来自国家药监局2026年11月11日公开披露的消息，2026年10月国家药监局累计批准130项进口第一类医疗器械产品备案事项，其中，进口第一类医疗器械首次备案25项；进口第一类医疗器械变更备案102项；进口第一类医疗器械取消备案3项，一起来看具体内容。

进口第一类医疗器械产品备案.jpg

2026年10月【进口第一类医疗器械产品备案】信息

医疗器械名称医疗器械备案号医疗器械备案人名称原文生产地址原文
荧光生物显微镜国械备20260238号EUROIMMUN   Medizinische Labordiagnostika AGAn   der Trave 1, 23923 Selmsdorf, Germany
医用橡胶检查手套国械备20260318号PT   LATEXINDO TOBAPERKASAJI.   Binjai Km 11, Mulyorejo - Sunggal 20352, Deli Serdang, Indonesia
医用橡胶检查手套国械备20260317号PT   LATEXINDO TOBAPERKASAJI.   Binjai Km 11, Mulyorejo - Sunggal 20352, Deli Serdang, Indonesia
肩关节手术工具国械备20260316号Zimmer   Inc.1800   W. Center Street Warsaw Indiana 46580 USA
眼用刮匙国械备20260315号Presbia   Ireland LimitedRockwood   Business Centre  Suite 201, Q House   Furze Road Sandyford Business Park    Dublin 18 D18 N6K8  Ireland
人工颈椎椎间盘手术工具国械备20170919号SPINEART   SAChemin   du Pré-Fleuri 3,1228 Plan-les-Ouates,Switzerland 
腰椎固定器国械备20260314号3M   CompanyLot   B_9B-CN, Na5 Road, My Phuoc II IZ, Ben Cat Ward, Ho Chi Minh City, Vietnam,   Postal code 75915
足部固定器国械备20260313号3M   CompanyLot   B_9B-CN, Na5 Road, My Phuoc II IZ, Ben Cat Ward, Ho Chi Minh City, Vietnam,   Postal code 75915
膝部固定器国械备20260312号3M   CompanyLot   B_9B-CN, Na5 Road, My Phuoc II IZ, Ben Cat Ward, Ho Chi Minh City, Vietnam,   Postal code 75915
腕关节固定器国械备20260311号3M   CompanyLot   B_9B-CN, Na5 Road, My Phuoc II IZ, Ben Cat Ward, Ho Chi Minh City, Vietnam,   Postal code 75915
医用外固定支具国械备20151493号DJO,LLCCarretera   Libre Tijuana Tecate #20230 Submetropoli EL florido,Tijuana B.C. Mexico 22244
全自动免疫检验系统用底物液国械备20160408号Phadia   ABRapsgatan   7P, P. O. Box 6460, 751 37 Uppsala, Sweden
样本稀释液国械备20160409号Phadia   ABRapsgatan   7P, P.O.Box 6460, 751 37 Uppsala
橡皮障国械备20151555号Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, Liechtenstein；No.10, Jalan Istimewa 1, Taman Perindustrian   Cemerlang, 81800 Ulu Tiram, Johor, Malaysia
全自动免疫检验系统用终止液国械备20160411号Phadia   ABRapsgatan   7P, P.O. Box 6460, 751 37 Uppsala
分类处理系统国械备20160289号Roche   Diagnostics GmbHMaybachstraβe   30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck,   Germany
分杯处理系统国械备20160134号Roche   Diagnostics GmbHMaybachstraβe   30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany
医用离心机国械备20160135号Roche   Diagnostics GmbHMaybachstraβe   30 - 71332 Waiblingen, Germany; Bernhardslaicher Weg 10-71686 Remseck Germany
生物显微镜国械备20250055号Leica   Microsystems CMS GmbHErnst-Leitz-Stra?e   17-37, 35578 Wetzlar, GERMANY
耳鼻喉科手术器械国械备20230192号KARL   STORZ SE & Co. KG见附件2
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 Kingdom
转移帽国械备20161140号DIO   Corporation66,   Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA
种植体扫描体国械备20161179号DIO   Corporation66,   Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA
器械钳国械备20191125号Geister   Medizintechnik GmbHF?hrenstr.2   78532 Tuttlingen, GERMANY
热塑膜国械备20260310号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium
人体定位垫国械备20260309号Orfit   IndustriesVosveld   9A 2110 Wijnegem Belgium
二氧化碳吸收剂（钙石灰）国械备20200539号ATRASORB   INDúSTRIA DE PRODUTOS HOSPITALARES LTDA. AVENIDA   PIRACICABA, 351, VILA NOVA SAO ROQUE, SAO ROQUE-SP - 18131-230, BRAZIL.
清洗液国械备20210331号IMMUNODIAGNOSTIC   SYSTEMS S.A.Rue   Ernest Solvay 101 4000 LIEGE BELGIUM
激发液 IDS-iSYS Trigger Set国械备20150840号Immunodiagnostic   Systems SArue   Ernest Solvay 101 4000 Liège, Belgium
清洗液国械备20210332号IMMUNODIAGNOSTIC   SYSTEMS S.A.Rue   Ernest Solvay 101 4000 LIEGE BELGIUM
耳镜国械备20260308号Yasco   InternationalBuilding   No. 6, Street No. 1, Jalal Pura, Near CA Gold City, Eimanabad Road,Sialkot,   Pakistan
喉镜国械备20260307号Yasco   InternationalBuilding   No. 6, Street No. 1, Jalal Pura, Near CA Gold City, Eimanabad Road,Sialkot,   Pakistan
CD15抗体试剂（流式细胞仪法-PC5）国械备20181291号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD16抗体试剂（流式细胞仪法-ECD）国械备20181292号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD10抗体试剂（流式细胞仪法-FITC） CD10-FITC国械备20181301号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD56抗体试剂（流式细胞仪法-ECD）国械备20181279号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD38抗体试剂（流式细胞仪法-PC5）CD38-PC5国械备20181242号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD38抗体试剂（流式细胞仪法-FITC） CD38-FITC国械备20181303号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD16抗体试剂（流式细胞仪法-PE）CD16-PE国械备20181229号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD38抗体试剂（流式细胞仪法-APC-Alexa Fluor 750）国械备20181296号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD62P抗体试剂（流式细胞仪法-FITC）国械备20181228号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
人类白细胞抗原DR抗体试剂（流式细胞仪法-PE）国械备20181243号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD79b抗体试剂（流式细胞仪法-PE） CD79b-PE国械备20181238号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD23抗体试剂（流式细胞仪法-FITC） CD23-FITC国械备20181241号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD71抗体试剂（流式细胞仪法-FITC） CD71-FITC国械备20181305号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD56抗体试剂（流式细胞仪法-APC-Alexa Fluor 700）国械备20181302号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
人类白细胞抗原DR抗体试剂（流式细胞仪法-ECD）国械备20181299号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD117抗体试剂（流式细胞仪法-PC7）国械备20181304号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD56抗体试剂（流式细胞仪法-APC） CD56-APC国械备20181290号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD11c抗体试剂（流式细胞仪法-PE） CD11c-PE国械备20181236号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD5抗体试剂（流式细胞仪法-PC7）CD5-PC7国械备20181432号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD5抗体试剂（流式细胞仪法-FITC） CD5-FITC国械备20181423号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD45抗体试剂（流式细胞仪法-APC-Alexa Fluor 750）国械备20181417号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD45抗体试剂（流式细胞仪法-Krome Orange）国械备20181424号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD3抗体试剂（流式细胞仪法-APC-Alexa Fluor 750）国械备20181429号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD45抗体试剂（流式细胞仪法-PC5.5）国械备20181439号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD69抗体试剂（流式细胞仪法-PC5）国械备20181237号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD14抗体试剂（流式细胞仪法-PC5） CD14-PC5国械备20181440号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD4抗体试剂（流式细胞仪法-APC） CD4-APC国械备20181420号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD3抗体试剂（流式细胞仪法-PC5.5）国械备20181422号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
CD56抗体试剂（流式细胞仪法-PC5） CD56-PC5国械备20181239号Immunotech   S.A.S (a Beckman Coulter Company) 130   Avenue de Lattre de Tassigny, BP 177, 13276, Marseille Cedex 9, France
CD8抗体试剂（流式细胞仪法-PC7)国械备20200666号Beckman   Coulter, Inc.740   West 83rd Street Hialeah, Florida 33014, USA
CD4抗体试剂(流式细胞仪法-PC7)国械备20200667号Beckman   Coulter, Inc.740   West 83rd Street Hialeah, Florida 33014, USA
医用检查手套国械备20150240号TOP   GLOVE SDN. BHD.Lot   4969, Jalan Teratai, Batu 6,Off Jalan Meru, 41050 Klang, Selangor Darul Ehsan
CD3抗体试剂（流式细胞仪法-PC7）国械备20200665号Beckman   Coulter, Inc.740   West 83rd Street Hialeah, Florida 33014, USA
CD38抗体试剂（流式细胞仪法-PC5.5）国械备20181278号Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 
拔牙钳国械备20160018号Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States
牙骨凿国械备20151353号Hu-Friedy   Mfg. Co., LLC美国伊利诺斯州芝加哥市北罗克韦尔大街3232号
免疫显色试剂国械备20260306号Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom
唇颊牵开器国械备20160659号Hu-Friedy   Mfg.Co.,LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States
基础外科手术器械国械备20260305号Miqraz   Surgical IndustriesKullu   Wall Road, Tibbi Arayan P.O.Box 1483 Sialkot-Pakistan
背部固定器国械备20260304号VALUE   & TRUST CO., LTD.4,   51 Hoam-ro, Buk-gu, Daegu, Republic of Korea
站立架国械备20191314号ALTIMATE   MEDICAL, INC.262   West First St. Morton, MN 56270
种植体安装辅助器械国械备20250275号radix   Implants & Biomaterials GmbHHirzenrott   2-4 52076 Aachen Germany
口腔科手术器械国械备20260302号Mira   SurgicalNo.   7, Noul More, Behind Total Pump, Wazirabad Road, Sialkot-51310-Pakistan
头灯国械备20170604号Geister   Medizintechnik GmbHF?hrenstr.   2, 78532 Tuttlingen, GERMANY
医用外固定支具国械备20161756号DJO,   LLC1）1430   Decision Street Vista, California, 92081, USA；2）Carretera Libre Tijuana   Tecate #20230 Submetropoli El Florido, Tijuana B. C. Mexico 22244
牙科种植专用器械包国械备20161332号DIO   Corporation66,   Centum seo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA
种植体扫描体国械备20260301号Terrats   Medical S.L.C/Mogoda   75-99, 08210, Barberà del V. (BCN) Spain
种植体扫描体国械备20260300号Terrats   Medical S.L.C/Mogoda   75-99, 08210, Barberà del V. (BCN) Spain
高速离心机国械备20170017号Beckman   Coulter, Inc.An   der Unteren Soese 50, 37520 Osterode, Germany
高速冷冻离心机国械备20170016号Beckman   Coulter, Inc.An   der Unteren Soese 50, 37520 Osterode, Germany
高速离心机国械备20140044号Beckman   Coulter, Inc.An   der Unteren Soese 50, 37520 Osterode, GERMANY
高速台式冷冻离心机国械备20220053号Beckman   Coulter,Inc.An   der Unteren Soese 50, 37520 Osterode, Germany
高速冷冻离心机国械备20140177号Beckman   Coulter, Inc.An   der Unteren Soese 50, 37520 Osterode, GERMANY
清洗液国械备20151528号富士レビオ株式会社1.   東京都八王子市小宮町５１番地; 2. 福井県敦賀市東洋町10番地24号
热塑膜国械备20200470号Orfit   IndustriesVosveld   9a 2110 Wijnegem Belgium
热塑膜国械备20230603号Orfit   Industries Vosveld 9A 2110 Wijnegem Belgium
瓣膜修复系统支撑固定操作台国械备20260299号Edwards   Lifesciences LLC26   Spur Dr, El Paso, TX USA 79906
牙用手术刀国械备20161103号Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States
牙科剪国械备20160003号Hu-Friedy   Mfg.Co.,LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States
牙龈刀国械备20160019号Hu-Friedy   Mfg. Co., LLC1666   E. Touhy Ave, Des Plaines, IL    60018-3607, United States
持针钳国械备20151230号Hu-Friedy   Mfg. Co., LLC美国伊利诺斯州芝加哥市北罗克韦尔大街3232号
替代体国械备20260298号Terrats   Medical S.L.C/Mogoda   75-99, 08210, Barberà del V. (BCN) Spain
牙科种植手术定位件国械备20260297号JDentalCare   S.r.l.Via   Dino Campana 2, 41123 Modena, ITALY
种植体安装辅助器械国械备20240285号Alpha   Dent Implants GmbH194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA) 
定位螺丝国械备20240286号Alpha   Dent Implants GmbH194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA) 
牙科种植用测量器国械备20240283号Alpha   Dent Implants GmbH194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)
口腔灯国械备20200564号Takara   Belmont Corporation2-6-59,   Kitatsumori, Nishinari-ku, Osaka, 557-0061, Japan
聚氨酯衬垫绷带国械备20170523号Lohmann   & Rauscher International GmbH & Co. KGIrlicher   Strasse 55, 56567 Neuwied, GERMANY
口腔科手术器械国械备20240240号NIBBLE   SURGICALAbyala，P/O   Box Dholo Bhelo，Sialkot-Pakistan
医用固定带国械备20171164号?????????????   ??? ??? ??? 395,(189-4)
医用高分子夹板国械备20181214号?????????????   ??? ??? ???395，(189-4)
种植体安装辅助器械国械备20240109号Izenimplant   Co., Ltd.1,   2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do
种植用牙钻限深导向器国械备20240093号Izenimplant   Co., Ltd.1,   2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do
手动测量用器械国械备20240091号Izenimplant   Co., Ltd. 1,   2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do
种植辅助材料国械备20240092号Izenimplant   Co., Ltd.1,   2Dong, 26-32, Suworam 4-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do
牙用充填器国械备20151612号LASCOD   S.P.A. (LABORATORI SCIENTIFICI ODONTOIATRIA)IT-50019   SESTO FIORENTINO (FI)-VIA L.LONGO, 18
显微外科手术器械国械备20160602号Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany
耳鼻喉科手术器械包国械备20200361号Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany
耳鼻喉科手术器械国械备20160604号Spiggle   & Theis Medizintechnik GmbHBurghof   14 51491 Overath Germany
样本稀释液国械备20161052号Beckman   Coulter, Inc.Route   de Cassel 59114 STEENVOORDE France
样本稀释液国械备20161398号Beckman   Coulter, Inc.1000   Lake Hazeltine Drive Chaska, MN 55318, USA
样本稀释液国械备20161399号Beckman   Coulter, Inc.1000   Lake Hazeltine Drive Chaska, MN 55318, USA
样本稀释液国械备20151356号Beckman   Coulter, Inc.1000   Lake Hazeltine Drive, Chaska, MN 55318-1084, USA 
样本稀释液国械备20161396号Beckman   Coulter, Inc.1000   Lake Hazeltine Drive Chaska, MN 55318, USA
样本稀释液国械备20150932号Beckman   Coulter, Inc.1000   Lake Hazeltine Drive, Chaska, MN 55318-1084, USA 
样本稀释液国械备20191443号Beckman   Coulter, Inc.130   Avenue de Lattre de Tassigny BP 177 Marseille, Cedex 9, 13276 France
样本稀释液国械备20161401号Beckman   Coulter, Inc.1000   Lake Hazeltine Drive Chaska, MN 55318, USA
样本稀释液国械备20161397号Beckman   Coulter, Inc.1000   Lake Hazeltine Drive Chaska, MN 55318, USA
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