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國(guó)家局7月批準(zhǔn)187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案
發(fā)布日期:2023-08-03 20:12瀏覽次數(shù):1282次
2023年8月2日,國(guó)家藥監(jiān)局發(fā)布進(jìn)口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)公告,2023年7月,國(guó)家局累計(jì)批準(zhǔn)頸椎固定器、醫(yī)用固定帶、脊柱微創(chuàng)手術(shù)工具包、醫(yī)用檢查手套、下肢醫(yī)用外固定支具、鉆針深度停止器、牙科成形片套裝等187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案。一起看正文。

2023年8月2日,國(guó)家藥監(jiān)局發(fā)布進(jìn)口第一類醫(yī)療器械產(chǎn)品備案數(shù)據(jù)公告,2023年7月,國(guó)家局累計(jì)批準(zhǔn)頸椎固定器、醫(yī)用固定帶、脊柱微創(chuàng)手術(shù)工具包、醫(yī)用檢查手套、下肢醫(yī)用外固定支具、鉆針深度停止器、牙科成形片套裝等187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案。一起看正文。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

國(guó)家局7月批準(zhǔn)187項(xiàng)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案

序號(hào)產(chǎn)品名稱備案號(hào)備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
1頸椎固定器國(guó)械備20170267號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
2醫(yī)用固定帶國(guó)械備20170246號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
3腰椎固定帶國(guó)械備20170245號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
4腕關(guān)節(jié)固定器國(guó)械備20210288號(hào)?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland 2023-07-31 變更
5腰部固定器國(guó)械備20190176號(hào)?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
6肩部固定器國(guó)械備20220071號(hào)?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
7踝部固定器國(guó)械備20220072號(hào)?ssur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
8頸部固定器國(guó)械備20181375號(hào)Ossur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
9胸腰骶固定器國(guó)械備20170217號(hào)?ssur   hf.Grjóthálsi   1 - 5, IS-110 Reykjavik, Iceland2023-07-31 變更
10下肢醫(yī)用外固定支具國(guó)械備20180444號(hào)Ossur   hfGrjotháls   1-5 Reykjavik 110 Iceland2023-07-31 變更
11宮腔活檢鉗國(guó)械備20230361號(hào)CooperSurgical,   Inc.Industriestr.24   D-78532 Tuttlinger Germany2023-07-31 有效
12醫(yī)用檢查手套國(guó)械備20210197號(hào)貝格莫特有限公司31,   Jalan Balakong Jaya 4, Taman Industri Balakong Jaya, Seri Kembangan,   Selangor, 43300, Malaysia2023-07-31 變更
13刀頭國(guó)械備20200736號(hào)ENDOVISION   Co., Ltd.66-26,   Dongnae-ro, Dong-gu. Daegu, Republic of Korea2023-07-28 變更
14脊柱微創(chuàng)手術(shù)工具包國(guó)械備20210050號(hào) ENDOVISION Co., Ltd.66-26,   Dongnae-ro, Dong-gu, Daegu, Republic of Korea2023-07-28 變更
15脊柱手術(shù)工具包國(guó)械備20200688號(hào)ENDOVISION   Co., Ltd.66-26,   Dongnae-ro, Dong-gu, Daegu, Republic of Korea2023-07-28 變更
16種植體安裝輔助器械包國(guó)械備20230360號(hào)Haenaem   Co., Ltd.194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)2023-07-27 有效
17醫(yī)用檢查手套國(guó)械備20230253號(hào)Koon   Seng Sdn.Bhd.PTD   16058,Kawasan Perindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-07-27 變更
18醫(yī)用檢查手套國(guó)械備20230254號(hào)Koon   Seng Sdn.Bhd.PTD   16058,KawasanPerindustrian Tangkak,JalanMuar,84900 Tangkak,Johor,Malaysia2023-07-27 變更
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20鉆針深度停止器國(guó)械備20230358號(hào)Haenaem   Co., Ltd.194,   Jisan-ro 175beon-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 17718 (Rep. of   KOREA)2023-07-27 有效
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27手術(shù)刀國(guó)械備20210443號(hào)Deusch   Medizintechnik GmbHEsslinger   StraBe 13,78532 Tuttlingen2023-07-25 變更
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32牙用尺國(guó)械備20161414號(hào)MIS   Implants Technologies Ltd.Bar   Lev Industrial Park, 2015600 Israel2023-07-24 變更
33種植安裝輔助工具包國(guó)械備20190883號(hào)MIS   Implants Technologies Ltd.P.O.   Box 7 Bar Lev Industrial Park, 2015600, Israel 2023-07-24 變更
34唇頰牽開器國(guó)械備20220479號(hào)Align   Technology, Inc.Ave.   La Cuspide No.1 Del. Playas de Tijuana, TIJUANA, Baja California Mexico 225002023-07-24 變更
35組織鑷國(guó)械備20230355號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-24 有效
36牽開器國(guó)械備20230354號(hào)BMC-PRIMA   GmbHHerrenbachstr.   17 73066 Uhingen Germany2023-07-24 有效
37血紅蛋白檢測(cè)用裝載片國(guó)械備20190477號(hào)Fresenius   Kabi AGVon-Cancrin-Straβe   1, 63877 Sailauf ,  Deutschland2023-07-24 變更
38頭戴式檢查燈國(guó)械備20230353號(hào)(?)?????????   ?? ?????26? 12 R&D?? 403?2023-07-24 有效
39醫(yī)用放大鏡國(guó)械備20230352號(hào)(?)?????????   ?? ?????26? 12 R&D?? 403?2023-07-24 有效
40正畸鉗國(guó)械備20180071號(hào)Ortho   Organizers, Inc.1.Ranger   H.Q. Road Cantt, Sialkot – Pakistan;2.3232 N. Rockwell Street, Chicago, IL,   60618, United States;3.Nasir Road, Sialkot-Pakistan2023-07-21 變更
41醫(yī)用檢查手套國(guó)械備20170208號(hào)Henry   Schein Services GmbHLot   1365, Batu 17, Jalan Sungai Sembilang, Jeram, Kuala Selangor, Selangor Darul   Ehsan 45800 Malaysia2023-07-21 變更
42正畸鉗國(guó)械備20160817號(hào)Ormco   Corporation1)   1332 South Lone Hill Avenue, Glendora, California,  91740, USA;
   
    2) Circuito Sur No.31, Parque Industrial Nelson, Mexicali, B.C. C.P. 21395,   Mexico
   
    3) Calle Industrial Del Acero No.18, parque Industrial EL Vigia Mexicali,   Baja California Mexico 21397
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43股骨干手術(shù)工具國(guó)械備20230351號(hào)SERF85   Avenue des Bruyères,69150 DECINES-CHARPIEU,F(xiàn)RANCE2023-07-21 有效
44CD28檢測(cè)試劑(流式細(xì)胞儀法)國(guó)械備20230350號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
45骨測(cè)量器國(guó)械備20200173號(hào)Rebstock   Instruments GmbHIn   Weiher Weiher?cker 7 78589 D Dürbheim Germany2023-07-20 無(wú)效
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47CD28檢測(cè)試劑(流式細(xì)胞儀法)國(guó)械備20230348號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-07-20 有效
48瑞氏染色液   ADVIA Autoslide Modified Wright Stain國(guó)械備20151834號(hào)Siemens   Healthcare Diagnostics Inc.4481   Campus Drive, Kalamazoo, Michigan 49008 USA2023-07-20 變更
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82眼科手術(shù)器械手柄國(guó)械備20220211號(hào)VOLK   OPTICAL INC.7893   ENTERPRISE DR. Mentor, OH USA 440602023-07-13 變更
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176泌尿肛腸外科手術(shù)器械國(guó)械備20180001號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG2023-07-27 無(wú)效
177矯形外科(骨科)手術(shù)器械國(guó)械備20171254號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG2023-07-27 無(wú)效
178耳鼻喉科手術(shù)器械 國(guó)械備20171242號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG2023-07-27 無(wú)效
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180基礎(chǔ)外科手術(shù)器械國(guó)械備20170581號(hào)Mill   Medical Instruments B.V.Unit   801B 8/F Trend Ctr 29 Cheung Lee St Chai Wan,Hong Kong2023-07-27 無(wú)效
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182胸腔心血管外科手術(shù)器械國(guó)械備20171239號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG2023-07-27 無(wú)效
183顯微外科手術(shù)器械國(guó)械備20171219號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG2023-07-27 無(wú)效
184口腔科手術(shù)器械國(guó)械備20171229號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG2023-07-27 無(wú)效
185眼科手術(shù)器械國(guó)械備20171234號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG2023-07-27 無(wú)效
186神經(jīng)外科手術(shù)器械國(guó)械備20171228號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG2023-07-27 無(wú)效
187基礎(chǔ)外科手術(shù)器械國(guó)械備20180031號(hào)Mill   Medical Instruments B.V.UNIT   801B 8/F TREND CTR 29 CHEUNG LEE ST CHAI WAN,HONG KONG.2023-07-27 無(wú)效

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