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进口第一类医疗器械产品备案信息(2021年08月)

发布日期:2025-11-06 20:05:57 浏览次数:

尽管资本市场更加关注高风险的第三类医疗器械,但也有好多经营一类医疗器械的企业取得优异经营绩效。2021年08月,共计123个进口第一类医疗器械产品备案获批,一起来看看有哪些产品。

进口第一类医疗器械产品备案信息(2021年08月)(图1)

进口第一类医疗器械产品备案信息(2021年08月)

序号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
1手术用头架国械备20161617号pro med instruments GmbHWaldmatten 6 79224 Umkirch Germany2021-08-31变更
2医用高分子夹板国械备20210464号3M Deutschland GmbHul. Kwidzynska 6, 51-416 Wroclaw, Poland2021-08-31有效
3ERG/TMPRSS2/ETV1/ETV4基因异常检测试剂盒(原位杂交法)国械备20180783号CytoTest Inc.9430 Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30变更
4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20180744号CytoTest Inc.9430 Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30变更
5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20180751号CytoTest Inc.9430 Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30变更
6TERC基因扩增检测试剂盒(原位杂交法)国械备20180748号CytoTest Inc.9430 Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30变更
7膀胱癌细胞染色体及基因异常检测试剂盒(原位杂交法)国械备20180746号CytoTest Inc.9430 Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30变更
8TOP2A基因扩增检测试剂盒(原位杂交法)国械备20180750号CytoTest Inc.9430 Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30变更
9原位杂交蓝染染色液国械备20180743号CytoTest Inc.9430 Key West Avenue Suite 210 Rockville, MD 20850 USA2021-08-30变更
10肩部手术固定装置国械备20210257号ALLEN MEDICAL SYSTEMS, INC.100 Discovery Way Acton, MA 017202021-08-30变更
11CD3检测试剂国械备20210463号Becton, Dickinson and Company, BD Biosciences2350 Qume Drive, San Jose, California 95131, USA;Vicks Drive, Lot 1 Corner Road 735, Cayey 00736 Puerto Rico2021-08-30有效
12颈前路钢板手术器械国械备20160171号Spineart SA20 route de pre-bois CP 1813 1215 Geneva(Switzerland)2021-08-27变更
13菌斑指示剂国械备20170830号Produits Dentaires SA18 rue des Bosquets,1800 Vevey, Switzerland2021-08-27变更
14磷酸盐铸造包埋材料国械备20170829号Produits Dentaires SA18 rue des Bosquets,1800 Vevey, Switzerland2021-08-27变更
15脱脂棉球国械备20170828号Produits Dentaires SA18 rue des Bosquets,1800 Vevey, Switzerland2021-08-27变更
16医用固定带国械备20151538号???? ???6,Hwasan-ro 101 beon-gil,Idong-myeon,Cheoin-gu,Yongin-si,Gyeonggi-do2021-08-27变更
17机用根管螺旋输送器国械备20181438号Produits Dentaires SA18 rue des Bosquets CH-1800 Vevey2021-08-27变更
18牙科抛光条国械备20181404号Produits Dentaires SA18 rue des Bosquets, CH-1800 Vevey2021-08-27变更
19根管锉国械备20180344号Produits Dentaires SA18 rue des Bosquets,1800 Vevey, Switzerland2021-08-27变更
20菌斑指示剂国械备20190173号Produits Dentaires SA18 rue des Bosquets CH-1800 Vevey2021-08-27变更
21一次性使用牙科冲洗针国械备20200662号Produits Dentaires SARue des Bosquets 18, 1800 Vevey, Switzerland2021-08-27变更
22螺丝起国械备20151268号Thommen Medical AGNeckarsulmstrasse 28, 2540 Grenchen, Switzerland2021-08-27变更
23牙科种植扫描体国械备20181655号Thommen Medical AGNeckarsulmstrasse 28,2540 Grenchen Switzerland2021-08-26变更
24替代体国械备20181415号Thommen Medical AGNeckarsulmstrasse 28,2540 Grenchen Switzerland2021-08-26变更
25牙科输送头国械备20210462号サンメディカル株式会社滋賀県守山市古高町571-22021-08-26有效
26髋关节手术工具包国械备20210461号AESCULAP AGAm Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-08-26有效
27膝关节手术工具包国械备20210460号AESCULAP AGAm Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-08-26有效
28咬骨钳国械备20210459号AESCULAP AGAm Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-08-26有效
29牙科电动抽吸系统国械备20210458号DüRR DENTAL SEH?pfigheimer Str.17,74321 Bietigheim-Bissingen,Germany2021-08-26有效
30置骨器国械备20170916号HumanTech Dental GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2021-08-25变更
31转移帽国械备20170917号HumanTech Dental GmbHGewerbestrasse 5,71144 Steinenbronn Germany2021-08-25变更
32钻针深度停止器国械备20171122号HumanTech Dental GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2021-08-25变更
33螺丝起国械备20171123号HumanTech Dental GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2021-08-25变更
34高速冷冻离心机国械备20171151号Beckman Coulter, Inc.5355 West 76th Street Indianapolis, IN 46268 USA2021-08-25变更
35高速离心机国械备20171152号Beckman Coulter, Inc.5355 West 76th Street Indianapolis, IN 46268 USA2021-08-25变更
36持钉器国械备20171121号HumanTech Dental GmbHGewerbestrasse 5, 71144 Steinenbronn, Germany2021-08-25变更
37高速冷冻离心机国械备20140268号Beckman Coulter, Inc.5355 West 76th St. Indianapolis, IN 46268 USA2021-08-25变更
38高速冷冻离心机国械备20150131号Beckman Coulter, Inc.5355 West 76th St. Indianapolis, IN 46268 USA2021-08-25变更
39牙科洁治器国械备20210457号POMEE USA INCMian Ilam Din Road, Doburji Arian Sialkot, Punjab, 51310, Pakistan2021-08-24有效
40试色糊剂国械备20210456号Dentsply Caulk38W. Clarke Avenue, Milford,Delaware,19963, USA2021-08-24有效
41牙科输送头国械备20200653号Sulzer Mixpac AGRütistrasse 7, CH-9469 Haag2021-08-24变更
42超速离心机国械备20170826号Beckman Coulter, Inc.5355 West 76th Street Indianapolis, IN 46268 USA2021-08-24变更
43医用检查手套国械备20190238号HARTALEGA SDN.BHD.No. 7, Kawasan Perusahaan Suria, Bestari Jaya, 45600 Selangor Darul Ehsan, MALAYSIA2021-08-24变更
44基础外科手术器械国械备20210455号Cardio Surgical Ltd.Clogan, Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2021-08-24有效
45胫骨托试模国械备20210454号DePuy Orthopaedics, Inc.47 Episcopal Rd., Berlin, Connecticut 06037 USA2021-08-24有效
46髋关节手术工具国械备20210453号DePuy International Limited8 Matchett Drive, Pierceton, Indiana 46562 USA2021-08-24有效
47手术刀片国械备20210452号ConMed Corporation525 French Road Utica, New York 13502, USA2021-08-23有效
48尿液研究用稀释液国械备20210451号Medica Corporation5 Oak Park Drive, Bedford, Massachusetts, 01730, United States2021-08-23有效
49创口贴国械备20200613号Young Chemical Co., Ltd80-93, Golden root-ro, Juchon-myeon, Gimhae-si, Gyeongsangnam-do, Korea2021-08-23变更
50手术动力系统工具国械备20210450号AESCULAP AGAm Aesculap-Platz, 78532 Tuttlingen, GERMANY2021-08-23有效
51骨传导植入式听力系统植入手术器械包国械备20210449号Elos Medtech Pinol A/SEngvej 33, G?rl?se 3330, Denmark2021-08-20有效
52弹力绷带国械备20210448号Paul Hartmann AGLauterstra?e 50, 67752 Wolfstein, GERMANY2021-08-20有效
53金刚石磨头国械备20181134号Spiggle & Theis Medizintechnik GmbHBurghof 14 51491 Overath Germany2021-08-19变更
54弹力绷带国械备20210447号Paul Hartmann AGLauterstra?e 50, 67752 Wolfstein, GERMANY2021-08-19有效
55牙科输送头国械备20200327号Pulpdent Corporation80 Oakland Street, Watertown, MA 02472 United States2021-08-19变更
56转移帽国械备20160722号ORNAGHI LUIGI & C.s.n.c.Via Santa Margherita,123-20861 BRUGHERIO(MB)-ITALIA2021-08-19变更
57牙科抛光磨头国械备20190282号Coltène/Whaledent AGKanalstrasse 18, 9490 Vaduz, Liechtenstein2021-08-19变更
58膝关节手术工具国械备20210446号Howmedica Osteonics Corp.325 Corporate Drive Mahwah, NJ 07430 USA;IDA Industrial Estate Carrigtwohill, County Cork, Ireland2021-08-17有效
59造口底盘国械备20190929号Coloplast A/SColoplast Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2021-08-17变更
60弹力套国械备20210445号SIGVARIS Inc. – Holland Facility13055 Riley St Ste 30, Holland, MI USA 494242021-08-17有效
61手术剪国械备20151004号Gebrüder Martin GmbH & Co. KGKLS Martin Platz 1, 78532 Tuttlingen, Germany2021-08-17变更
62组织镊国械备20151273号Gebrüder Martin GmbH & Co. KGKLS Martin Platz 1, 78532 Tuttlingen, Germany2021-08-17变更
63持针钳国械备20151311号Gebrüder Martin GmbH & Co. KGKLS Martin Platz 1, 78532 Tuttlingen, Germany2021-08-17变更
64样本稀释液国械备20152164号Siemens Healthcare Diagnostics Inc.333 Coney Street, East Walpole, Massachusetts 02032, USA2021-08-17变更
65造口底盘国械备20190932号Coloplast A/SColoplast Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2021-08-17变更
66钩针国械备20210444号Deusch Medizintechnik GmbHEsslinger StraBe 13,78532Tuttlingen2021-08-17有效
67手术刀国械备20210443号Deusch Medizintechnik GmbHEsslinger StraBe 13,78532Tuttlingen2021-08-17有效
68骨科手术器械包国械备20180204号MAKO SURGICAL CORP.见申请表附件2021-08-16变更
69成人与儿童骨科手术器械国械备20210442号best medical GmbHHeudorfer Straβe 32 78576 Emmingen-Liptingen Germany2021-08-16有效
70牙科输送头国械备20210441号ネオ製藥工業株式会社長野県松本市大字与田4010番172021-08-16有效
71成人与儿童显微外科手术器械国械备20210440号best medical GmbHHeudorfer Straβe 32 78576 Emmingen-Liptingen Germany2021-08-16有效
72苏木素-伊红染色液(H-E)国械备20210439号Leica Biosystems Richmond, Inc.5205 Route 12 P.O.Box 528 Richmond Illinois 60071 USA2021-08-16有效
73口腔科用定位杆国械备20210438号Osstem Implant Co.,Ltd.66-16, Bansong-ro, 513beon-gil, Haeundae-gu, Busan2021-08-16有效
74前处理缓冲液B国械备20190668号Kreatech Biotechnology B.V.Vlierweg 20, 1032 LG Amsterdam, The Netherlands2021-08-16变更
75冲洗缓冲液V国械备20190667号Kreatech Biotechnology B.V.Vlierweg 20, 1032 LG Amsterdam, The Netherlands2021-08-16变更
76TERC基因扩增探针试剂(原位杂交法)国械备20181384号KREATECH Biotechnology BVVlierweg 20, 1032 LG Amsterdam, The Netherlands2021-08-16变更
77TOP2A基因扩增探针试剂(原位杂交法)国械备20181383号KREATECH Biotechnology BVVlierweg 20, 1032 LG Amsterdam, The Netherlands2021-08-16变更
78替代体国械备20181180号ORNAGHI LUIGI & C.S.n.c.Via Santa Margherita, 123-20861 BRUGHERIO (MB)2021-08-13变更
79替代体国械备20181179号ORNAGHI LUIGI & C.S.n.c.Via Santa Margherita, 123-20861 BRUGHERIO (MB)2021-08-13变更
80替代体国械备20181178号ORNAGHI LUIGI & C.S.n.c.Via Santa Margherita, 123-20861 BRUGHERIO (MB)2021-08-13变更
81牙科种植用延长器国械备20200258号ORNAGHI LUIGI & C. S.n.c.Via S. Margherita, 131 - 20861 BRUGHERIO (MB) - ITALIA2021-08-13变更
82膝关节手术工具国械备20160144号SOCIETA AZIONARIA MATERIALE OSPEDALIERO-S.A.M.O.S.P.A.Via G. Matteotti, 37 40057 Cadriano di Granarolo Emilia BO Italia/Via Buozzi,13-15-40057 Cadriano,Granarolo,Bologna,ITALY2021-08-13变更
83髋关节手术工具国械备20161334号SOCIETA AZIONARIA MATERIALE OSPEDALIERO-S.A.M.O.S.p.a.Via G. Matteotti, 37 40057 Cadriano di Granarolo Emilia BO Italia2021-08-13变更
84医用手持式压力泵国械备20160976号VBM Medizintechnik GmbHEinsteinstr. 1, 72172 Sulz a. N. Germany2021-08-12变更
85膝关节手术工具国械备20181367号Zimmer Inc.1800 W. Center Street, Warsaw, Indiana 46580 USA2021-08-12变更
86成人与儿童耳鼻喉科手术器械国械备20210437号best medical GmbHHeudorfer Straβe 32 78576 Emmingen-Liptingen Germany2021-08-11有效
87手术刀国械备20151355号LandangerZI La Vendue,FR-52906 Chaumont Cedex 92021-08-11变更
88神经与心血管手术器械国械备20210436号Cardio Surgical Ltd.Clogan, Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2021-08-11有效
89骨科手术器械国械备20210435号Cardio Surgical Ltd.Clogan, Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland2021-08-11有效
90刮匙国械备20210434号FENTEXmedical GmbHtake-off Gewerbepark 2 78579 Neuhausen Ob Eck Germany2021-08-10有效
91钢丝穿引器国械备20152023号Waldemar Link GmbH & Co.KGBarkhausenweg 10 22339 Hamburg

GERMANY
2021-08-10变更
92钢丝钳国械备20152043号Waldemar Link GmbH & Co.KGBarkhausenweg 10 22339 Hamburg GERMANY2021-08-10变更
93起子国械备20180206号MAKO Surgical Corp.130 Durham Dr., Athens, AL 35611, USA2021-08-10变更
94股骨假体试模国械备20210433号DePuy Orthopaedics, Inc.486 West 350 North, Warsaw, Indiana 46582 USA; 811 Northwoods Blvd., Vandalia, Ohio 45377 USA2021-08-10有效
95膝关节手术导板国械备20210432号DePuy International Limited486 West 350 North, Warsaw, Indiana 46582 USA2021-08-10有效
96膝关节手术工具国械备20160853号Biomet Orthopedics56 East Bell Drive,P.O.Box 587, Warsaw Indiana 46581 USA2021-08-10变更
97膝关节手术工具包国械备20160975号Biomet Orthopedics56 East Bell Drive,P.O.Box 587, Warsaw Indiana 46581 USA2021-08-10变更
98试模国械备20180022号MAKO Surgical Corp.2555 Davie Road Fort Lauderdale, Florida 333172021-08-09变更
99打入器国械备20180202号MAKO SURGICAL CORP.2429 North Burdick St. Kalamazoo, MI 490072021-08-09变更
100外科手术固定装置国械备20190115号MAKO SURGICAL CORP.见附件。2021-08-09变更
101CD45检测试剂国械备20210431号BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-08-09有效
102CD33检测试剂国械备20210430号BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-08-09有效
103CD23检测试剂国械备20210429号BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-08-09有效
104CD11b检测试剂国械备20210428号BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-08-09有效
105快装手柄国械备20210427号愛派司生技股份有限公司新北市中与區橋与路120號2樓之22021-08-09有效
106骨定位针国械备20210426号愛派司生技股份有限公司新北市中与區橋与路120號2樓之22021-08-09有效
107骨科钻头国械备20210425号愛派司生技股份有限公司新北市中与區橋与路120號2樓之22021-08-09有效
108一次性使用末梢采血管国械备20210424号NEOTERYX, LLC421 Amapola Avenue Torrance, CA USA 905012021-08-09有效
109肋骨固定板国械备20161361号Chrisofix Hungary Kft.Grassalkovich út 272-274. 1239 Budapest Hungary2021-08-09变更
110医用高分子夹板国械备20150041号Chrisofix Hungary Kft.Grassalkovichút 272. 1239 Budapest Hungary2021-08-09变更
111转运车国械备20180633号Linet spol. s r.o.?elevcice 5, 274 01 Slany, CZECH REPUBLIC2021-08-06变更
112孵育器国械备20151334号Grifols Diagnostic Solutions Inc./401 Millcreek Road, Marietta, Ohio 45750-4304 USA401 Millcreek Road, Marietta, Ohio 45750-4304 USA2021-08-05变更
113软轴牵开器国械备20161616号pro med instruments GmbHBoetzinger Strasse 38 79111 Freiburg Germany2021-08-04变更
114膝关节矫形工具包国械备20180529号MAKO Surgical Corp.见附页2021-08-03变更
115膝关节手术器械包国械备20190071号MAKO SURGICAL CORP.见附件。2021-08-03变更
116膝关节手术器械包国械备20200624号MAKO SURGICAL CORP.见附件2021-08-03变更
117骨传导植入式听力系统植入手术器械包国械备20210423号Cochlear Bone Anchored Solutions ABKonstruktionsvagen 14, SE-435 33 Molnlycke, Sweden2021-08-03有效
118轮转式切片机国械备20210422号Milestone S.r.l.CL LLEIDA, 17-23. 43712 - LLOREN? DEL PENEDES (TARRAGONA)2021-08-02有效
119质谱样品处理基质国械备20140127号Bruker Daltonics GmbH & Co. KGFahrenheitstrasse 4,28359 Bremen,Germany2021-08-02变更
120缓冲液 MBT Sepsityper IVD Kit国械备20151332号Bruker Daltonics GmbH & Co. KGFahrenheitstrasse 4, 28359 Bremen, GERMANY2021-08-02变更
121成人与儿童基础外科手术器械国械备20210421号best medical GmbHHeudorfer Straβe 32 78576 Emmingen-Liptingen Germany2021-08-02有效
122自动染片机20151830号lumatas BioSystems Inc47747 Warm Springs Blvd Fremont , CA USA 945392021-08-23变更
123自动染片机20180689号lumatas BioSystems Inc47747 Warm Springs Blvd Fremont , CA USA 945392021-08-23变更
建议新入行朋友可以多关注进口第一类医疗器械产品备案信息。



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