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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:2021-09-07 23:05浏览次数:5528次
尽管资本市场更加看重高风险的第三类医疗器械,但也有许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。

尽管资本市场更加看重高风险的第三类医疗器械,但也有许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.jpg

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 USA 2021-08-25 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 USA 2021-08-25 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, MALAYSIA 2021-08-24 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尿液分析用稀释液国械备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 13,78532 Tuttlingen2021-08-17 有效
67手术刀国械备20210443号Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2021-08-17 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成人和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和田4010番172021-08-16 有效
71成人和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成人和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神经和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和區橋和路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和區橋和路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和區橋和路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成人和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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