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進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息（2021年10月）
發(fā)布日期:2021-11-07 10:10瀏覽次數(shù):3214次
2021年11月4日，國家藥監(jiān)局公布《進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息（2021年10月）》，2021年10月，共計(jì)批準(zhǔn)56個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案?。

2021年11月4日，國家藥監(jiān)局公布《進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息（2021年10月）》，2021年10月，共計(jì)批準(zhǔn)56個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案。如下表所示：

2021年10月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
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腦電/肌電導(dǎo)聯(lián)線國械備20210518號(hào)Natus Neurology Incorporated3150 Pleasant View Road Middleton, Wisconsin 53562 USA;IDA Business Park Gort Co.Galway Ireland.2021-10-29 有效
2一次性使用細(xì)胞過濾采集器國械備20210517號(hào)Hologic, Inc.4 Navigator Road, Londonderry, New Hampshire 03053, USA2021-10-29 有效
3細(xì)胞保存液國械備20210516號(hào)Hologic, Inc.4 Navigator Road, Londonderry, New Hampshire 03053, USA2021-10-29 有效
4全自動(dòng)免疫檢驗(yàn)系統(tǒng)用底物液國械備20160413號(hào)富士レビオ株式會(huì)社東京都八王子市小宮町５１番地2021-10-29 變更
5樣本稀釋液國械備20160414號(hào)富士レビオ株式會(huì)社東京都八王子市小宮町51番地2021-10-29 變更
6基礎(chǔ)外科手術(shù)器械國械備20210515號(hào)PHEASANT INTERNATIONAL CORP.Nai Abadi Murad Pur, Sialkot - Pakistan2021-10-28 有效
7口腔隔離器具國械備20170181號(hào)(?)??42-25, Dongsan-Ro 27beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea Rep.2021-10-28 變更
8CD8檢測試劑國械備20210514號(hào)BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-10-27 有效
9CD14檢測試劑國械備20210513號(hào)BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-10-27 有效
10CD2檢測試劑國械備20210512號(hào)BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-10-27 有效
11CD33檢測試劑國械備20210511號(hào)BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-10-27 有效
12CD5檢測試劑國械備20210510號(hào)BioLegend, Inc.8999 BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212021-10-27 有效
13扭力扳手國械備20171138號(hào)MIS Implants Technologies Ltd.Bar Lev Industrial Park,2015600 Israel2021-10-27 變更
14電動(dòng)移位車國械備20210509號(hào)株式會(huì)社FUJI74-1, AZA SHAGUCHI, NISHIHONGO-CHO, OKAZAKI-SHI, AICHI, 444-0947, JAPAN2021-10-26 有效
15血型分析用稀釋液國械備20160416號(hào)Diagnostic Grifols, S.A.Passeig Fluvial,24. 08150-Parets del Vallès, Barcelona, Spain2021-10-26 變更
16造口護(hù)膚粉國械備20191349號(hào)Hollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2021-10-26 變更
17防漏膏國械備20190580號(hào)Hollister Incorporated 366 Draft Avenue Stuarts Draft, VA 24477 USA2021-10-26 變更
18三丙胺緩沖液國械備20171106號(hào)Roche Diagnostics GmbHSandhofer Strasse116, 68305 Mannheim, Germany2021-10-25 變更
19取模與轉(zhuǎn)移配件國械備20210508號(hào)ZUGA MEDICAL, INC.300 Park Place, Suite A, Chagrin Falls, OH, USA 440222021-10-21 有效
20X射線防護(hù)裝置國械備20181414號(hào)Kenex (Electro-Medical) LtdUnit 17, RO24 Greenway, Harlow Business Park, Harlow, Essex, CM19 5QB,UK2021-10-21 變更
21大容量冷凍離心機(jī)國械備20140278號(hào)Thermo Electron LED GmbH Zweigniederlassung OsterodeAm Kalkberg, 37520 Osterode am Harz, Germany2021-10-20 無效
22打磨拋光清潔器具國械備20210507號(hào)Garrison Dental Solutions LLC19, Hayezira St., Ra’anana, Israel; Neureutstra?e 6 75210 Keltern Germany2021-10-20 有效
23醫(yī)用超聲波清洗器國械備20210506號(hào)STERIS CorporationUnits 7 & 8 Stortford Hall Industrial Park Dunmow Road Bishop’s Stortford Hertfordshire CM23 5GZ United Kingdom2021-10-20 有效
24人工晶狀體植入器國械備20210505號(hào)Alcon Laboratories, Incorporated714 Columbia Avenue, Sinking Spring PA 19608, USA2021-10-18 有效
25脊柱內(nèi)固定系統(tǒng)手術(shù)工具國械備20181056號(hào)Zimmer Biomet Spine, Inc.10225 Westmoor Drive, Westminster, Colorado 80021, USA; 5400 Meltech Blvd. Suite 119, Memphis, Tennessee 38118, USA2021-10-15 變更
26脊柱撐開器國械備20150414號(hào)Zimmer SpineCité Mondiale 23, Parvis des Chartrons, 33080 Bordeaux, France2021-10-15 變更
27脊柱手術(shù)器械包國械備20150712號(hào)Zimmer GmbHSulzerallee 8, Winterthur, 8404, Switzerland2021-10-15 變更
28高速離心機(jī)國械備20140044號(hào)Beckman Coulter, Inc.An der Unteren Soese 50, 37520 Osterode, GERMANY2021-10-14 變更
29醫(yī)用離心機(jī)國械備20140178號(hào)Beckman coulter, Inc.An der Unteren Soese 50, 37520 Osterode, GERMANY2021-10-14 變更
30高速冷凍離心機(jī)國械備20140177號(hào)Beckman Coulter, Inc.An der Unteren Soese 50, 37520 Osterode, GERMANY2021-10-14 變更
31高速離心機(jī)國械備20170017號(hào)Beckman Coulter, Inc.An der Unteren Soese 50, 37520 Osterode, Germany2021-10-14 變更
32高速冷凍離心機(jī)國械備20170016號(hào)Beckman Coulter, Inc.An der Unteren Soese 50, 37520 Osterode, Germany2021-10-13 變更
33牙科拋光條國械備20181404號(hào)Produits Dentaires SA18 rue des Bosquets, CH-1800 Vevey2021-10-13 變更
34肌電導(dǎo)聯(lián)線國械備20210504號(hào)Natus Manufacturing LimitedIDA Business Park Gort Co.Galway Ireland2021-10-12 有效
35口腔觀察儀國械備20161431號(hào)晉弘科技股份有限公司新竹市東區(qū)科學(xué)園區(qū)研發(fā)二路7號(hào)1樓2021-10-12 變更
36全自動(dòng)樣品處理系統(tǒng)國械備20210503號(hào)Thermo Fisher Scientific OyRatastie 2, FI-01620, Vantaa Finland2021-10-12 有效
37尿液有形成分染色包國械備20181718號(hào)東洋紡株式會(huì)社福井県敦賀市東洋町10番24號(hào)2021-10-12 變更
38尿液分析用染色液國械備20180813號(hào)東洋紡株式會(huì)社10-24, Toyo-cho, Tsuruga, Fukui, 914-8550 JAPAN2021-10-12 變更
39石膏鑄造包埋材料國械備20170468號(hào)Ransom & Randolph, LLC570 West College Avenue, York, Pennsylvania, 17401, USA2021-10-11 變更
40口鏡國械備20210502號(hào)賈雷格斯實(shí)業(yè)有限公司臺(tái)中市潭子區(qū)豐栗路100巷88弄8號(hào)2021-10-11 有效
41印模材料輸送器國械備20170810號(hào)3M Deutschland GmbHOhmstra?e 3, 86899 Landsberg, Germany2021-10-11 變更
42橡皮障夾國械備20150074號(hào)Kerr CorporationVia Strecce 4, 6934 Bioggio, Switzerland2021-10-11 變更
43橡皮障國械備20170006號(hào)Kerr CorporationVia Strecce 4 P.O. 272 6934 Bioggio Switzerland2021-10-11 變更
44止血鉗國械備20210501號(hào)AURIGA INTERNATIONALShahab Pura Near Gepco Colony Ugoki Road, S.I.E Sialkot - Pakistan2021-10-09 有效
45剪切鉗國械備20210500號(hào)AURIGA INTERNATIONALShahab Pura Near Gepco Colony Ugoki Road, S.I.E Sialkot - Pakistan2021-10-09 有效
46剝離器國械備20210499號(hào)AURIGA INTERNATIONALShahab Pura Near Gepco Colony Ugoki Road, S.I.E Sialkot - Pakistan2021-10-09 有效
47刀柄國械備20210498號(hào)AURIGA INTERNATIONALShahab Pura Near Gepco Colony Ugoki Road, S.I.E Sialkot - Pakistan2021-10-09 有效
48血壓袖帶國械備20210497號(hào)GE Medical Systems Information Technologies, Inc.Calle Valle Del Cedro 1551, Juarez, Mexico 32575； 1F, 2F, 5F No.21 Jiankang Rd., Jhonghe Dist. New Taipei City 235, Taiwan2021-10-09 有效
49人體定位袋國械備20180866號(hào)MEDTEC,Inc.1401 8th St.SE,Orange City,IA,51041,United States2021-10-09 變更
50神經(jīng)根拉鉤國械備20150435號(hào)Zimmer SpineCité Mondiale 23, Parvis des Chartrons, 33080 Bordeaux, France2021-10-08 變更
51打入器國械備20150462號(hào)Zimmer SpineCité Mondiale 23, Parvis des Chartrons, 33080 Bordeaux, France2021-10-08 變更
52拔出器國械備20150531號(hào)Zimmer SpineCité Mondiale 23, Parvis des Chartrons, 33080 Bordeaux, France2021-10-08 變更
53打拔器 國械備20150550號(hào)Zimmer SpineCite Mondiale 23, Parvis des Chartrons, 33080 Bordeaux, France2021-10-08 變更
54測深器國械備20150534號(hào)Zimmer SpineCité Mondiale 23, Parvis des Chartrons, 33080 Bordeaux, France2021-10-08 變更
55醫(yī)用頭燈國械備20210495號(hào)OpInstruments GmbHBessemerstrasse 7, 60388 Frankfurt am Main, Germany2021-10-08 有效
56開口錐國械備20151933號(hào)LDR MEDICALH?tel de Bureaux 1, 4 rue Gustave Eiffel 10430 ROSIERES PRES TROYES FRANCE2021-10-08 變更

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