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
关于我们
公司简介
联系我们
联系我们

公众号二维码.jpg

 联系电话：0571-86198618手机: 18058734169 (微信同)手机:18868735317（微信同)周一至周日 8:00~22:00
在线客服周一至周日 8:00~22:00

QQ在线客服

 

当前位置：网站首页>关于我们>新闻动态
2023年11月进口第一类医疗器械产品备案信息
发布日期:2023-12-06 17:36浏览次数:3389次
2023年12月06日，国家药监局发布《2023年11月进口第一类医疗器械产品备案信息》，2023年11月累计批准180个进口第一类医疗器械产品备案产品。

2023年12月06日，国家药监局发布《2023年11月进口第一类医疗器械产品备案信息》，2023年11月累计批准180个进口第一类医疗器械产品备案产品。

进口第一类医疗器械产品备案.jpg

2023年11月进口第一类医疗器械产品备案信息

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膝关节手术工具国械备20210189号DePuy   Ireland UC请见附件“生产地址”。2023-11-30 变更
2肩关节全肩肩盂侧工具国械备20230564号DePuy   Orthopaedics, Inc.8   Matchett Drive, Pierceton, Indiana 46562, USA;   6688 Dixie Hwy., Bridgeport, Michigan   48722, USA;2023-11-30 有效
3动力系统配套工具国械备20210630号 Synthes GmbHEimattstrasse   3, 4436 Oberdorf, Switzerland2023-11-30 变更
4肩关节手术工具国械备20230563号Biomet   Orthopedics56   East Bell Drive, P.O. Box 587,Warsaw, Indiana 46581,USA2023-11-30 有效
5样本稀释液国械备20150458号Medirox   ABStudsvik,   611 82 NYK?PING, Sweden2023-11-30 变更
6基础外科手术器械国械备20230562号SURGICAL   SOURCES INDUSTRIESUgoki   Darbar Road, Near Zoom Petrol Filling Station, Sialkot - Pakistan2023-11-30 有效
7基础外科手术器械国械备20230561号Sehgal's   InstrumentsGhumman   St. Daska Road Pakki Kotli 51340 Sialkot Pakistan.2023-11-30 有效
8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) ITALY2023-11-30 变更
9牙科种植扫描体国械备20200085号Zirkonzahn   SrlZona   Industriale Molini di Tures 3 39032 Campo Tures (BZ), Italy2023-11-30 变更
10医用婴儿床国械备20191436号Advanced   Healthcare Technology Ltd.Northern   Road Sudbury Suffolk CO10 2ZB UK2023-11-30 变更
11剥离器国械备20152132号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-29 变更
12PD-1（CD279）检测试剂（流式细胞仪法)国械备20230560号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
13CD9抗体试剂（流式细胞仪法）国械备20230559号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
14CD41检测试剂（流式细胞仪法）国械备20230558号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-28 有效
15造口皮肤保护剂国械备20191366号ConvaTec   LimitedUNIT   22, VALLEY ROAD BUSINESS PARK, BIDSTON, WIRRAL, MERSEYSIDE. CH41 7EL, UNITED   KINGDOM2023-11-28 变更
16显微剪国械备20161108号ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 无效
17鼻剪国械备20180399号ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 无效
18扁桃体剪国械备20180397号ANTON   HIPP GmbH Annastr.25/1,78567   Fridingen,Germany2023-11-28 无效
19石膏剪国械备20180394号ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 无效
20组织剪国械备20180395号ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-28 无效
21钢丝剪国械备20180299号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
22显微钩国械备20180495号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
23探针国械备20180499号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
24手术刀国械备20180498号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
25骨刮匙国械备20180565号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
26显微剪国械备20180396号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
27骨膜剥离器 国械备20180563号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
28显微剥离器国械备20161109号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
29椎板牵开器国械备20180496号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
30显微冲洗吸引管国械备20161155号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
31 冷冻切片机  国械备20161064号 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 变更
32 冷冻切片机 国械备20150367号Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 变更
33冷冻切片机 国械备20161067号Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 变更
34冷冻切片机 国械备20180127号 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19, 69226 Nussloch, Germany2023-11-28 变更
35冷冻切片机国械备20161066号 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 变更
36染色机国械备20171212号Leica   Biosystems Nussloch GmbH1750A   Costner Drive Warrington, PA189762023-11-28 变更
37染色机 国械备20151853号 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2023-11-28 变更
38真空垫国械备20230557号Qfix 440   Church Road Avondale Pennsylvania 19311 USA2023-11-28 有效
39显微针国械备20180564号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-28 无效
40定位膜国械备20230556号Qfix440   Church Road Avondale Pennsylvania 19311 USA2023-11-28 有效
41口腔科手术器械国械备20230555号Sehgal's   InstrumentsGhumman   St. Daska Road Pakki Kotli 51340 Sialkot Pakistan.2023-11-27 有效
42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2023-11-27 变更
43关节假体夹持器国械备20152021号 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-11-27 变更
44牙科吸潮纸尖国械备20230554号C?ng   ty TNHH Gapadent Vi?t NamL?   B-B4 C?m c?ng nghi?p Hà Lam - Ch? ???c, x? Bình Ph?c, huy?n Th?ng Bình, t?nh   Qu?ng Nam, Vi?t Nam2023-11-27 有效
45眼科植入物及辅助器械国械备20230553号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
46眼用冲吸器及手柄国械备20230552号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
47眼科用铲国械备20230551号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
48眼用碎核器国械备20230550号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
49眼用碎核器国械备20230549号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
50角膜标记环国械备20230548号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
51角膜标记环国械备20230546号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
52 钻石手术刀国械备20230545号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
53眼用镊国械备20220542号KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-11-27 变更
54钻石手术刀国械备20230544号KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-11-27 有效
55抛光清洁器具国械备20230543号W&H   Dentalwerk Bürmoos GmbHCarl-Zeiss-Strasse   16, 77656 Offenburg, Germany2023-11-27 有效
56全自动血沉分析仪国械备20230541号ALIFAX   S.r.l.Via   Merano 30 33045 Nimis (UD) Italy2023-11-24 有效
57医学图像体外定位贴国械备20230540号Zimmer   CAS75   Queen Street, Suite 3300, Montreal, Quebec H3C 2N6, Canada2023-11-24 有效
58头灯国械备20160035号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
59医用检查音叉国械备20171244号RZ   Medizintechnik GmnHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 变更
60手外科固定复位镊国械备20171154号RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 变更
61显微剪国械备20170856号RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 变更
62显微持针镊国械备20170855号RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 变更
63显微止血夹国械备20170848号RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2023-11-23 变更
64显微镊国械备20170009号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
65吸引管国械备20160141号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
66口腔开口器国械备20160034号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
67钩针国械备20160033号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
68骨锤国械备20160030号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
69探针国械备20160028号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
70手术刀国械备20152117号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
71外科牵开器国械备20152120号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
72 支撑喉镜国械备20180222号RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany 2023-11-23 变更
73医用镊国械备20152116号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
74骨锉国械备20152119号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
75鼻窥器国械备20152118号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
76骨凿 国械备20152131号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
77刮匙国械备20151685号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
78医用剪国械备20151641号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
79止血钳 国械备20151642号RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 变更
80组织钳国械备20150692号RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 变更
81持针钳国械备20150693号RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2023-11-23 变更
82咬骨钳国械备20150690号RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2023-11-23 变更
83口腔科手术器械国械备20230539号SURGICAL   SOURCES INDUSTRIESUgoki   Darbar Road, Near Zoom Petrol Filling Station, Sialkot - Pakistan2023-11-23 有效
84颅骨牵引器国械备20180497号ANTON   HIPP GmbHAnnastr.   D-25/1, 78567 Fridingen, Germany2023-11-23 无效
85显微镊国械备20161111号ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 无效
86咬骨钳国械备20161156号ANTON   HIPP GmbH Annastr.25/1,78567   Fridingen,Germany2023-11-23 无效
87纱布绷带剪国械备20180298号ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 无效
88显微持针钳国械备20161110号ANTON   HIPP GmbHAnnastr.25/1,78567   Fridingen,Germany2023-11-23 无效
89耳鼻喉科手术器械包国械备20170904号Integra   LifeSciences Production Corporation/2023-11-23 变更
90夹持钳国械备20210024号グンゼ株式会社京都府綾部市青野町棗ヶ市462023-11-22 无效
91聚左旋乳酸可吸收骨固定系统配套工具国械备20181627号グンゼ株式会社京都府綾部市青野町棗ヶ市462023-11-22 无效
92牙科种植手术工具国械备20170168号Institut   Straumann AGPeter   Merian-Weg 12，4002 Basel，Switzerland； Les Champs du Clos 2，2613   Villeret，Switzerland； 60 Minuteman Road，Andover，MA，01810，USA2023-11-21 变更
93创伤外科手术器械包国械备20220635号Synthes   GmbH详见附件2023-11-20 变更
94骨科手术器械国械备20200275号Synthes   GmbH见附件。2023-11-20 变更
95医用检查手套国械备20230538号Sri   Trang Gloves (Thailand) Public Company Limited110/19   Ban Khao Mai Daeng, Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160,   THAILAND2023-11-20 有效
96医用检查手套国械备20230537号Sri   Trang Gloves (Thailand) Public Company Limited110/19   Ban Khao Mai Daeng, Moo 7, Phlai Wat, Kanchanadit, Surat Thani 84160,   THAILAND2023-11-20 有效
97牙科手术器械包国械备20230536号MIHHA   ENTERPRISESNizam   Street, Kotli Behram, Sialkot-Pakistan2023-11-20 有效
98医用检查手套国械备20170895号Sri   Trang Gloves (Thailand) Public Company Limited110   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2023-11-20 变更
99橡皮障夹钳国械备20191288号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-17 变更
100医用退热贴 国械备20171169号新タック化成株式会社香川県三豊市豊中町上高野4148番地2023-11-16 变更
101拔牙钳国械备20191261号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
102牙科剪国械备20191259号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
103阻生齿牙挺国械备20191264号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
104牙探针国械备20191285号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
105口腔麻醉剂手动助推器国械备20191345号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
106牙骨膜分离器国械备20191265号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
107橡皮膏 国械备20151099号Lohmann   & Rauscher International GmbH & Co.KGWesterwaldstraβe   4,56579 Rengsdorf GERMANY2023-11-16 无效
108颈部固定器国械备20170969号Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany2023-11-16 变更
109位置定位器国械备20160638号Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 变更
110牙用尺国械备20160637号Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 变更
111转移帽国械备20160639号Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 变更
112螺丝起国械备20160640号Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 变更
113牙科种植定位器国械备20160653号Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 变更
114转移帽国械备20161044号Dentis   Co., Ltd#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 变更
115代型材料国械备20170121号Dentis   Co., Ltd.#99,   Seongseoseo-Ro, Dalseo-Gu, Daegu, Korea2023-11-16 变更
116口镜国械备20191279号COMMIC   SURGICO罗拉丝路，诺切区，锡亚尔科特市，邮编51310，巴基斯坦2023-11-16 变更
117牙用充填器国械备20191260号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
118橡皮障夹国械备20191291号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
119牙用镊国械备20191263号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
120成形片夹国械备20191262号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
121牙科器械钳国械备20191258号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
122正畸钳国械备20191254号COMMIC   SURGICORoras   Road,Noul Chowk Sialkot-51310-Pakistan2023-11-16 变更
123脱钙液国械备20230535号Milestone   s.r.l.Via   Fatebenefratelli,1/5 IT-24010 SORISOLE (BG) Corso Europa,6 IT-24030 Valbrembo   (BG)2023-11-16 有效
124扭力扳手国械备20230257号????   ????????   ??? ?????4? 23-32023-11-15 变更
125足托固定器国械备20161906号Ottobock   SE & Co. KGaAMax-N?der-Stra?e   15, 37115 Duderstadt, Germany2023-11-15 变更
126肩关节固定器国械备20171259号Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany2023-11-15 变更
127创伤外科手术器械包国械备20180944号Synthes   GmbH见附件2023-11-15 变更
128一件式造口袋国械备20200123号ConvaTec   LimitedCarretera   Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2023-11-15 变更
129骨科保护支具国械备20230534号Bort   GmbHAm   Schweizerbach 1, 71384 Weinstadt-Benzach，Germany2023-11-15 有效
130返蓝染色液国械备20151291号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup Denmark2023-11-14 变更
131眼用镊国械备20230533号Vortex   Surgical, Inc.4   Research Park, Suite 124 St. Charles, MO 63304 USA 2023-11-14 有效
132清洗液   Artisan 50x Wash Solution国械备20150166号Agilent   Technologies, Inc.6392   Via Real Carpinteria, CA 930132023-11-14 变更
133创口贴国械备20230532号Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
134防水创可贴国械备20230531号Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
135创口贴国械备20230530号Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
136医用压敏胶带国械备20230529号Beiersdorf   AGCtra.de   Mataró a Granollers P .Km 5,6,08310 Argentona (Barcelona) ,Spanien2023-11-14 有效
137引流袋系统国械备20230528号怡安醫療器材股份有限公司臺灣省台中市梧棲區經三路39號2023-11-14 有效
138全自动核酸提取纯化仪国械备20230527号Promega   Corporation1017,   A Building Gangseo-Hangang-Xi Tower 401, Yangcheon-ro Gangseo-gu Seoul 07528   Republic of Korea2023-11-14 有效
139核酸提取或纯化试剂国械备20230526号Promega   Corporation2800   Woods Hollow Road Madison Wisconsin 53711-5399 USA2023-11-14 有效
140核酸提取或纯化试剂国械备20230525号Promega   Corporation2800   Woods Hollow Road Madison Wisconsin 53711-5399 USA2023-11-14 有效
141螺丝起国械备20150871号???????(?)66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2023-11-13 变更
142牙用尺国械备20150781号Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2023-11-13 变更
143扭力扳手国械备20150782号Osstem   Implant Co.,Ltd.66-16,   Bansong-ro 513beon-gil, Haeundae-gu, Busan, Korea2023-11-13 变更
144缝隙封闭糊剂国械备20190276号 Ultradent Products, Inc. 505   West Ultradent Drive (10200 South), South Jordan, Utah 84095, USA2023-11-13 变更
145牙科成形片套装国械备20230524号AFRZ   CORPORATIONRoras   Road, Near Makki Masjid, Sialkot - Pakistan2023-11-09 有效
146牙科抛光器械国械备20230523号AFRZ   CORPORATIONRoras   Road, Near Makki Masjid, Sialkot - Pakistan2023-11-09 有效
147血细胞分析用稀释液国械备20230522号シスメックス株式会社17   Takumidai, Ono, Hyogo 675-1322, Japan2023-11-09 有效
148血细胞分析用溶血剂国械备20230521号シスメックス株式会社17   Takumidai, Ono, Hyogo 675-1322, Japan2023-11-09 有效
149CD79a检测试剂国械备20230520号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-09 有效
150CD79a检测试剂国械备20230519号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-09 有效
151CD103检测试剂国械备20230518号BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-11-09 有效
152漏斗胸手术器械包国械备20161051号Biomet   Microfixation见附件2023-11-08 变更
153增强液（免疫组化法）国械备20190911号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark;1170 Mark Ave. Carpinteria, CA 93013 United   States2023-11-08 变更
154增强液  EnVision FLEX+ Rabbit LINKER (Dako Omnis)国械备20140028号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup Denmark2023-11-08 变更
155医用干式激光胶片国械备20230517号COLENTA   Labortechnik GmbH & Co.KGNeunkirchner   Straβe 117,2700 Wiener Neustadt, Austria2023-11-08 有效
156膝关节手术器械包国械备20190071号MAKO   SURGICAL CORP.见附件。2023-11-07 变更
157眼科手术非接触观察装置国械备20230516号OCULUS   Optikger?te GmbHMünchholzh?user   Str.29, 35582 Wetzlar, GERMANY2023-11-07 有效
158样本萃取液及流动相溶剂包(串联质谱法)国械备20140120号Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 变更
159清洗液国械备20140011号Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 变更
160诱导剂国械备20151616号Wallac   Oy华莱克有限公司2023-11-07 变更
161诱导剂国械备20150676号Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 变更
162样本稀释液国械备20150733号Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 变更
163增强液国械备20151617号Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 变更
164清洗液国械备20140370号Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 变更
165样本稀释液国械备20150740号Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2023-11-07 变更
166腰部固定器国械备20190176号?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-11-06 变更
167骨科手术器械国械备20180816号Synthes   GmbH见附件。2023-11-06 变更
168倒置生物显微镜国械备20230515号株式会社二コン471,   Nagaodai-Cho, Sakae-Ku, Yokohama, Kanagawa, 244-8533, Japan2023-11-03 有效
169高速离心机国械备20180864号Eppendorf   SEPortitzer   Allee 15, 04329 Leipzig, Germany;       175 Freshwater Boulevard, Enfield CT 06082, USA2023-11-03 变更
170导航手术工具国械备20190893号Medtronic   Navigation, Inc.826   Coal Creek Circle Louisville, CO 80027 United States of America2023-11-02 变更
171套管国械备20200001号Medtronic   Powered Surgical Solutions4620   North Beach Street Fort Worth Texas 76137 USA2023-11-02 变更
172口腔科器械国械备20230514号Easy   Source SurgicalHouse   No.7/4,Mohaliah Rang Pura,PindiArayian,Sialkot-51310,Pakistan2023-11-01 有效
173人工晶状体植入器国械备20210234号Johnson   & Johnson Surgical Vision, Inc.8600   Evergreen Boulevard, Minneapolis MN 55433, USA2023-11-01 变更
174核酸提取试剂国械备20171233号MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 无效
175核酸提取试剂国械备20160566号MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 无效
176核酸提取试剂国械备20160040号MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 无效
177核酸提取试剂国械备20160127号MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 无效
178核酸提取试剂国械备20160126号MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 无效
179核酸提取试剂国械备20160487号MP   Biomedicals Asia Pacific Pte Ltd2F.-2,   No.122, Qiaohe Rd., Zhonghe Dist., New Taipei City 235, Taiwan（R.O.C.）2023-11-02 无效
180聚左旋乳酸可吸收骨固定系统配套工具国械备20140081号グンゼ株式会社京都府绫部市青野町枣之市462023-11-22 无效

如有进口第一类医疗器械产品备案代办服务需求，欢迎您随时方便与杭州证标客医药技术咨询有限公司联络，联系人：叶工，电话：18058734169，微信同。

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