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当前位置：网站首页>新闻动态 >2026年5月进口第一类医疗器械产品备案信息
2026年5月进口第一类医疗器械产品备案信息
发布日期:2026-06-09 00:00浏览次数:36次
2026年6月8日，国家药监局公开披露了2026年5月进口第一类医疗器械产品备案信息，2026年5月国家批准了扭力扳手、医用射线防护眼镜、肘部固定器、踝部固定器、膝部固定器、口腔科器械、牙用尺、医用座垫、牙科种植器械工具、颈椎固定器、替代体、牙科用毛刷等109个进口第一类医疗器械备案产品，一起来看具体内容。

2026年6月8日，国家药监局公开披露了2026年5月进口第一类医疗器械产品备案信息，2026年5月国家批准了扭力扳手、医用射线防护眼镜、肘部固定器、踝部固定器、膝部固定器、口腔科器械、牙用尺、医用座垫、牙科种植器械工具、颈椎固定器、替代体、牙科用毛刷等109个进口第一类医疗器械备案产品，一起来看具体内容。

进口第一类医疗器械产品备案.jpg

2026年5月进口第一类医疗器械产品备案信息

产品名称备案号备案人名称原文生产地址原文
扭力扳手国械备20151905号Dentium   Co., Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Korea
医用射线防护眼镜国械备20151884号MAVIG   GmbHStahlgruberring   5，81829 München, GERMANY
肘部固定器国械备20260153号3M   CompanySF   No. 138 & 137/2C, Rayarthottam, Trichy Road, Kannampalayam, Sulur,   Coimbatore-641402, Tamil Nadu, India
踝部固定器国械备20260152号3M   CompanySF   No. 138 & 137/2C, Rayarthottam, Trichy Road, Kannampalayam, Sulur,   Coimbatore-641402, Tamil Nadu, India
膝部固定器国械备20260151号3M   CompanySF   No. 138 & 137/2C, Rayarthottam, Trichy Road, Kannampalayam, Sulur,   Coimbatore-641402, Tamil Nadu, India
口腔科器械国械备20260150号FINE   MED INSTRUMENTSUggoki   Road Near Darbar Dhattal,Sialkot,51310-Pakistan
牙用尺国械备20171039号Anthogyr2237   avenue André Lasquin, 74700 SALLANCHES FRANCE
医用座垫国械备20190325号Sunrise   Medical (US) LLC2842   Business Park Avenue Fresno, CA USA 93727
牙科种植器械工具国械备20240264号8dent   Inc.20-13,   Seogimhaesandan-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea
颈椎固定器国械备20181284号?????   ?????????   ??? ????6?49, 601?(???2?, ????)
替代体国械备20190867号ZimVie   US Corp LLC.（1）4555   Riverside Drive, Palm Beach Gardens, Florida 33410, USA； （2）C/Islas Baleares,   50 Pol. Ind. Fuente de Jarro Paterna , Valencia 46988 Spain
牙科用毛刷国械备20260149号medmix   Switzerland AGRütistrasse   7, 9469 Haag, Switzerland
螺丝起国械备20190934号ZimVie   US Corp LLC.（1）4555   Riverside Drive, Palm Beach Gardens, Florida 33410, USA； （2）C/Islas Baleares,   50 Pol. Ind. Fuente de Jarro Paterna , Valencia 46988 Spain
CD4抗体试剂国械备20260148号BioLegend,Inc.8999   BioLegend Way, San Diego, CA USA 92121
PD-1（CD279）检测试剂（流式细胞仪法)国械备20260147号BioLegend,Inc.8999   BioLegend Way, San Diego, CA USA 92121
医用检查手套国械备20260146号PT   Latexindo TobaperkasaJl.   Binjai Km 11, Mulyorejo – Sunggal 20352, Deli Serdang, Indonesia
医用检查手套国械备20260145号PT   Latexindo TobaperkasaJl.   Binjai Km 11, Mulyorejo – Sunggal 20352, Deli Serdang, Indonesia
医用透气胶带国械备20200150号ニチバン株式会社福岡県朝仓郡筑前町野町字禅門橋1713番地
弹力绷带国械备20200471号Thuasne   LLC167   Marks Creek Ln Hamlet，NC USA 28345
压力绷带国械备20240405号Thuasne   LLC167   Marks Creek Lane Hamlet North Carolina 28345 USA
核酸提取或纯化试剂国械备20180021号Promega   Corporation2800   Woods Hollow Road Madison, Wisconsin, 53711-5399, USA
核酸提取或纯化试剂国械备20180020号Promega   Corporation2800   Woods Hollow Road Madison, Wisconsin, 53711-5399, USA
诊察辅助器械国械备20260144号ISHAGO   SURGICALMOHALLAH   ISLAMABAD,UGOKI,(51310) SIALKOT-PAKISTAN
正颌手术器械包国械备20260143号KLS   Martin SE & Co.KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany
滋养层细胞表面抗原2（TROP2）抗体试剂（免疫组织化学法）国械备20260142号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA
种植辅助材料国械备20260141号Alpha   Dent Implants GmbHHanauer   Stra?e 1-5, 75181, Pforzheim, Germany
肘部固定器国械备20260140号BSN   medical GmbHNo.   68 & 88, Sec. 2, Zhongke Erlin Blvd., Mei-fang Vil., Erlin Township,   Changhua County, Taiwan
踝部固定器国械备20260139号BSN   medical GmbHNo.   68 & 88, Sec. 2, Zhongke Erlin Blvd., Mei-fang Vil., Erlin Township,   Changhua County, Taiwan
腕关节固定器国械备20260138号BSN   medical GmbHNo.   68 & 88, Sec. 2, Zhongke Erlin Blvd., Mei-fang Vil., Erlin Township,   Changhua County, Taiwan
膝部固定器国械备20260137号BSN   medical GmbHNo.   68 & 88, Sec. 2, Zhongke Erlin Blvd., Mei-fang Vil., Erlin Township,   Changhua County, Taiwan
医用压敏胶带国械备20161281号Solventum   Germany GmbHEdisonstraβe   6, 59157 Kamen, Germany
空心钻国械备20190162号Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany
牙科修整用金刚砂车针国械备20230154号Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany
牙科修整用钨钢车针国械备20230139号Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany
牙科修整用钨钢车针国械备20190638号Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany
牙科修整用金刚砂车针国械备20190637号Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany
牙科种植手术辅助器械包国械备20161777号Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss Deutschland
口腔科手术器械国械备20200690号Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany
牙科骨磨国械备20210248号Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss, Deutschland
骨科电钻头国械备20230155号Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany
螺丝起国械备20170497号Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss, Deutschland
打磨抛光组件国械备20170149号Hager   & Meisinger GmbHHansemannstraβe   10, 41468 Neuss Deutschland 
医用外固定四肢及关节支具国械备20160885号彪仕醫技股份有限公司台南市南区中华西路一段23号
耳镜国械备20190465号Tyto   Care Ltd.12   Haomanut Street Netanya,4250445,Israel
负压引流接管国械备20200382号Smith   & Nephew Medical LimitedSor   Juana Ines de la Cruz  #20150, Interior   5 Cd. Industrial Tijuana  Baja   California CP 22444 Mexico
高速离心机国械备20200714号Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany
高速冷冻离心机国械备20170331号Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany
高速离心机国械备20171120号Eppendorf   SEBarkhausenweg   1, 22339 Hamburg, Germany
造口袋国械备20190949号Coloplast   A/SKerék   utca 4, 2800 Tatabánya, Hungary
造口袋国械备20200704号Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya , Hungary
滑动标尺国械备20260136号DIXI   MEDICAL2A   route de Pouligney Chaudefontaine    25640 MARCHAUX-CHAUDEFONTAINE FRANCE 
测深器国械备20260135号DIXI   MEDICAL2A   route de Pouligney Chaudefontaine    25640 MARCHAUX-CHAUDEFONTAINE FRANCE 
印模转移杆国械备20190965号SHINHUNG   MST CO., LTD.110-2，Donghwagongdan-ro，Munmak-eup，Wonju-si，Gangwon-do，26365，Rep.   of KOREA
牙科种植用深度测量尺国械备20260134号SHINHUNG   MST CO., LTD.110-2,   Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea Rep.
牙刮匙国械备20260133号SHINHUNG   MST CO., LTD.110-2,   Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea Rep.
种植体安装辅助器械国械备20260132号SHINHUNG   MST CO., LTD.110-2,   Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do, Korea Rep.
血管钳国械备20151735号KLS   Martin SE & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany
骨科牵引架国械备20260131号MAQUET   GmbHKehler   Str. 31, 76437 Rastatt, Germany
耳鼻喉用开口器国械备20250081号FENTEXmedical   GmbHtake-off   Gewerbepark 2 78579 Neuhausen Ob Eck Germany
牙种植导向模板国械备20161432号Dentium   Co.,Ltd.150,   Eondong-ro, Giheung-gu, Yongin-si, Gyeonggi-do
骨磨引导器国械备20160305号Nobel   Biocare AB  Dimbov?gen   2, SE-691 51 Karlskoga ,Sweden；22715 Savi Ranch Parkway, Yorba Linda   California, 92887 USA；Engvej 33, 3330 G?rl?se, Denmark.
螺丝起国械备20151914号Nobel   Biocare AB22715   Savi Ranch Parkway Yorba Linda California 92887 USA; Dimbov?gen 2 SE-691 51   Karlskoga Sweden; Engvej 33 3330 G?rl?se Denmark;74950 SCIONZIER France;Rue   de Boujean 122 CH-2501 Biel/Bienne
钻针引导器国械备20160301号Nobel   Biocare AB22715   Savi Ranch Parkway Yorba Linda California 92887 USA; Dimbov?gen 2 SE-691 51   Karlskoga Sweden; Engvej 33, 3330 G?rl?se, Denmark
种植体螺丝起国械备20151826号Nobel   Biocare AB Dimbov?gen   2 SE-691 51 Karlskoga Sweden；  22715   Savi Ranch Parkway Yorba Linda California 92887 USA；Engvej 33, 3330 G?rl?se,   Denmark；74950 SCIONZIER France
牙种植定位杆国械备20160177号Nobel   Biocare AB Dimbov?gen   2 SE-691 51 Karlskoga Sweden；22715 Savi Ranch Parkway Yorba Linda California   92887 USA；Engvej 33, 3330 G?rl?se, Denmark；74950 SCIONZIER France
牙科输送头国械备20200404号Solventum   Germany GmbHRütistrasse   7, CH-9469 Haag
输氧面罩国械备20210258号新廣業股份有限公司台中市神岡區社口里中山路312號
组织脱水机国械备20190239号Shandon   Diagnostics Limited, a subsidiary of EprediaTudor   Road Manor Park Runcorn WA7 1TA Cheshire United Kingdom
创口贴国械备20180861号ニチバン株式会社日本福岡県朝倉郡筑前町野町字禅門橋1713
器械钳国械备20260130号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
医用镊国械备20260129号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
止血夹国械备20260128号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
组织钳国械备20260127号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
显微血管测量尺国械备20260126号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
血管钳国械备20260125号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
吸引管国械备20260124号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
手术刀柄国械备20260123号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
拉钩国械备20260122号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
打结器国械备20260121号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
手术剪国械备20260120号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
施夹钳国械备20260119号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
牵开器国械备20260118号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
超声洁牙机工作尖国械备20181533号慶暐醫療器材科技股份有限公司基隆市安樂區武訓街80號
膝部固定器国械备20260117号BSN   medical GmbHOrganize   Sanayi B?lgesi No:16 Salihli/Manisa
踝部固定器国械备20260116号BSN   medical GmbHOrganize   Sanayi B?lgesi No:16 Salihli/Manisa
腰部固定器国械备20260115号BSN   medical GmbHOrganize   Sanayi B?lgesi No:16 Salihli/Manisa
腕关节固定器国械备20260114号BSN   medical GmbHOrganize   Sanayi B?lgesi No:16 Salihli/Manisa
视力表投影仪国械备20190500号Huvitz   Co., Ltd. （1F，4F，5F）38,Burim-ro   170beon-gil,Dongan-gu,Anyang-si,Gyeonggi-do,14055,Republic of Korea 
持针钳国械备20260113号Cardio   Medical GmbHIndustriestra?e   3A 30855 Langenhagen Germany
显微组织镊国械备20160264号LeMaitre   Vascular, Inc.63   Second Avenue, Burlington, MA 01803
防辐射帽国械备20260112号Dr.   Goos-Suprema GmbHBrechtelstrasse   29, 69126 Heidelberg, Germany
种植体植入手术器械包国械备20170276号ZimVie   US Corp LLC.1900   Aston Avenue, Carlsbad, CA 92008, USA
口腔科技工室用抛光保护帽国械备20210009号ZimVie   US Corp LLC.（1）4555   Riverside Drive, Palm Beach Gardens, Florida 33410,USA； （2）C/Islas Baleares,   50 Pol. Ind. Fuente de Jarro Paterna , Valencia 46988 Spain
口腔科手术器械国械备20210165号ORTHOMECHANIX   EXIMPGunjian   Wali Khurd，Sialkot Pakistan
膝关节手术工具国械备20260111号Zimmer   Inc.1800   W. Center Street Warsaw Indiana 46580 USA
弹力绷带国械备20200504号medi   GmbH & Co. KGMedicusstraβe   1, 95448 Bayreuth, Germany
弹力绷带国械备20200642号medi   GmbH & Co.KG6481   Franz Warner Parkway, Whitsett, NC 27377 United States
可挤压式四肢压力带国械备20200636号medi   GmbH & Co.KG6481   Franz Warner Parkway, Whitsett, NC 27377 United States
弹力绷带国械备20161524号Medi   GmbH & Co. KGMedicusstraβe   1, 95448 Bayreuth, Germany
压力绷带国械备20240409号medi   GmbH & Co. KGCamino   de Torrefarrera, Km 0,200, 25110, Alpicat, Lleida, Spain
压力绷带国械备20240097号medi   GmbH & Co. KGCamino   de Torrefarrera, Km 0,200, 25110, Alpicat, Lleida, Spain
腰部固定器国械备20240411号medi   GmbH & Co. KGOrganize   Sanayi B?lgesi No. 16, Salihli, Manisa, Turkey
膝部固定器国械备20240410号medi   GmbH & Co. KGOrganize   Sanayi B?lgesi No. 16, Salihli, Manisa, Turkey
足部固定器国械备20250138号medi   GmbH & Co. KGElbringhausen   2 + 4, 42929 Wermelskirchen, Germany
腰部固定器国械备20240153号medi   GmbH & Co. KG?.p.   71, 679 53 Bene?ov, Czech Republic
上肢固定器国械备20240412号medi   GmbH & Co. KG?.p.   71, 67953 Bene?ov, Czech Republic
踝部固定器国械备20240413号medi   GmbH & Co. KG?.p.   71, 67953 Bene?ov, Czech Republic
样本稀释液国械备20260110号東ソー株式会社日本国富山県富山市岩瀬古志町   2 番地
可挤压式四肢压力带国械备20200240号medi   GmbH & Co.KGMedicusstraβe   1, 95448 Bayreuth, Germany

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