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2020年11月進口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2020-12-08 11:01瀏覽次數(shù):4328次
醫(yī)療器械價值與醫(yī)療器械是一類、二類、還是三類存在關系，但在多年執(zhí)業(yè)過程中，也看到許多一類醫(yī)療器械具有很好的臨床應用價值和經(jīng)濟價值。近日，藥監(jiān)總局發(fā)布2020年11月進口第一類醫(yī)療器械產(chǎn)品備案?信息，共計226個進口第一類醫(yī)療器械產(chǎn)品備案被批準。

引言：醫(yī)療器械價值與醫(yī)療器械是一類、二類、還是三類存在關系，但在多年執(zhí)業(yè)過程中，也看到許多一類醫(yī)療器械具有很好的臨床應用價值和經(jīng)濟價值。近日，藥監(jiān)總局發(fā)布2020年11月進口第一類醫(yī)療器械產(chǎn)品備案信息，共計226個進口第一類醫(yī)療器械產(chǎn)品備案被批準。

第一類醫(yī)療器械產(chǎn)品備案.jpg

2020年11月進口第一類醫(yī)療器械產(chǎn)品備案信息

序號產(chǎn)品名稱備案號備案人名稱原文生產(chǎn)地址原文備案日期狀態(tài)
1球囊擴張充壓裝置國械備20200689號株式會社ICST埼玉県さぃたま市中央?yún)^(qū)上落合5丁目17-1S-4タワー；埼玉県北足立郡伊奈町壽2丁目311；栃木県足利市江川町2丁目17番122020-11-30 有效
2脊柱手術工具包國械備20200688號ENDOVISION   Co., Ltd.66-26,   Dongnae-ro, Dong-gu, Daegu, Republic of Korea2020-11-30 有效
3一件式造口袋國械備20181569號Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-30 變更
4造口底盤國械備20190932號Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2020-11-30 變更
5造口護理用品國械備20181590號Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-30 變更
6正畸鉗國械備20160817號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		2020-11-27 變更
7牽開器國械備20200687號CM   Instrumente GmbH  G?ns?cker   56，78532 Tuttlingen，Germany2020-11-27 有效
8種植體掃描體國械備20161179號DIO   Corporation66,   Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2020-11-27 變更
9造口皮膚保護膜國械備20190111號Coloplast   A/STeampac   Oy, Dunkatie 4, 07880 Liljendal, Finland2020-11-27 變更
10造口袋國械備20181653號Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-27 變更
11測瓣器套裝國械備20150500號Edwards   Lifesciences LLCOne   Edwards Way Irvine, CA 926142020-11-27 變更
12二件式造口袋國械備20190784號Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-27 變更
13造口皮膚保護劑國械備20191410號Coloplast   A/Sul.Szczakowska   35, 43-600 Jaworzno, Poland2020-11-27 變更
14醫(yī)用圖像打印機國械備20200686號Agfa   NVMax-Planck-Str.   1, 82380, Peiβenberg, Germany2020-11-26 有效
15牙科磷酸鹽鑄造包埋材國械備20200685號SRL   Dental GmbHGiulinistra?e   2 67065 Ludwigshafen Germany2020-11-26 有效
16機動基臺螺絲起國械備20200684號TALLADIUM   ESPA?A, S.L.C/VIRGINIA   WOOLF 17-25005 LLEIDA SPAIN2020-11-26 有效
17血細胞分析用染色液國械備20200683號RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2020-11-26 有效
18緩沖液國械備20200682號RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2020-11-26 有效
19骨測量器國械備20152049   號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2020-11-25 變更
20骨錐 國械備20152024號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
21固定針國械備20152047號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2020-11-25 變更
22骨科定位片 國械備20152031號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
23打入器國械備20152032號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2020-11-25 變更
24 骨拉鉤國械備20152012號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
25打拔器國械備20152033號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2020-11-25 變更
26峨眉鑿國械備20151880號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg Germany2020-11-25 變更
27口腔科手術器械國械備20200681號ASAS   AND BROTHERS ENTERPRISESModel   Town,Ugoki,Sialkot,Pakistan2020-11-25 有效
28骨撬國械備20152018號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
29試色糊劑國械備20190250號Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, Liechtenstein2020-11-25 變更
30骨刮匙國械備20152020號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
31夾持器國械備20152021號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
32鋼絲穿引器國械備20152023號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2020-11-25 變更
33骨銼國械備20152019號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY
   
    		2020-11-25 變更
34吉姆薩染色液國械備20140176號Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA2020-11-25 變更
35血細胞分析用溶血劑 國械備20161504號Beckman   Coulter, Inc.Parc   Euromedicine-Rue du Caducee, BP 7290, 34184 Montpellier Cedex 4, France2020-11-25 變更
36血細胞分析用染色液國械備20161505號Beckman   Coulter, Inc.Parc   Euromedicine-Rue du Caducee, BP 7290, 34184 Montpellier Cedex 4, France2020-11-25 變更
37血細胞分析用染色液國械備20170266號Beckman   Coulter, Inc.7381   Empire Drive, Florence, KY 41042, USA2020-11-25 變更
38緩沖液國械備20140233號Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA2020-11-25 變更
39緩沖液國械備20140237號Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA2020-11-25 變更
40瑞氏-吉姆薩染色液國械備20140179號Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA2020-11-25 變更
41瑞氏染色液國械備20140187號Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA 2020-11-25 變更
42血細胞分析用染色液國械備20170213號Beckman   Coulter, Inc.740   W 83rd Street, Hialeah, FL 33014, USA2020-11-25 變更
43血細胞分析用稀釋液國械備20140159號Beckman   coulter, Inc.7381   Empire Drive, Florence, Kentucky 41042, USA2020-11-25 變更
44血細胞分析用溶血劑國械備20140184號Beckman   coulter, Inc.7381   Empire Drive, Florence, Kentucky 41042, USA2020-11-25 變更
45血細胞分析用染色液國械備20151293號Beckman   coulter, Inc.7381   Empire Drive, Florence, Kentucky 41042, USA2020-11-25 變更
46全自動推片染片系統(tǒng)國械備20160725號Beckman   Coulter, Inc.11800   SW 147th Ave., Miami, FL 33196 USA2020-11-25 變更
47測瓣器國械備20200680號St.   Jude Medical177   County Road B East St. Paul Minnesota 55117 USA2020-11-25 有效
48截骨板國械備20152139號Waldemar   Link GmbH & Co. KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
49髖臼銼國械備20152138號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
50填充塊國械備20152137號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
51尿液分析用鞘液   iQ? LaminaTM國械備20150059號Beckman   Coulter Ireland Inc.7381   Empire Drive, Florence, Kentucky 41042, USA2020-11-25 變更
52髓腔銼國械備20152136號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
53清洗液   iChem? VELOCITY(TM) Wash Solution國械備20140183號Beckman   Coulter Ireland Inc. 2470   Faraday Avenue Carlsbad CA 92010 USA2020-11-25 變更
54鋼絲鉗國械備20152043號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
55扳手國械備20152042號 Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2020-11-25 變更
56體液分析用溶血劑   iQ? Body Fluids Lysing Reagent 國械備20150226號Beckman   Coulter Ireland Inc.2470   Faraday Avenue Carlsbad, CA 92010 USA2020-11-25 變更
57導鉆 國械備20152045號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
58血細胞分析用稀釋液國械備20180178號Beckman   Coulter Ireland Inc. Europark Fichtenhain B13, 47807 Krefeld,   Germany 2020-11-25 變更
59拔出器 國械備20152044號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY		2020-11-25 變更
60血細胞分析用染色液國械備20200679號RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2020-11-25 有效
61骨用牽開器國械備20152127號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
62取出鉗國械備20152126號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
63血細胞分析用溶血劑國械備20180180號 Beckman Coulter Ireland Inc.Multiparc   du Salaison Bat 13, 145 rue de la Marbrerie, 34740 Vendargues, FRANCE2020-11-25 變更
64試模國械備20152129號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
65尿液分析用稀釋液   Iris? Diluent Pack 國械備20140182號Beckman   Coulter Ireland Inc.2470   Faraday Avenue Carlsbad CA 92010 USA2020-11-25 變更
66血細胞分析用染色液國械備20200678號RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2020-11-25 有效
67快裝手柄國械備20152128號Waldemar   Link GmbH & Co. KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
68髓腔鉸刀國械備20152135號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
69扭斷器國械備20152130號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
70自動樣本處理系統(tǒng)國械備20150277號Beckman   Coulter, Inc.8-14-30   Nagaminehigashi, Higashi-ku, Kumamoto-shi, Kumamoto-ken Japan2020-11-25 變更
71全自動樣品處理系統(tǒng)國械備20181379號Beckman   Coulter Biomedical GmbHRupert-Mayer-Strasse   44 Muenchen 81379 Germany2020-11-25 變更
72自動樣本處理系統(tǒng)國械備20151466號Beckman   Coulter, Inc.8-14-30   Nagaminehigashi, Higashi-ku, Kumamoto-shi, Kumamoto-ken Japan  2020-11-25 變更
73頸椎前路固定板系統(tǒng)手術工具國械備20170832號bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2020-11-24 變更
74骨刀國械備20200677號CM   Instrumente GmbH  G?ns?cker   56，78532 Tuttlingen，Germany2020-11-24 有效
75鞘液濃縮液國械備20200676號Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2020-11-24 有效
76鞘液國械備20200675號Luminex   Corporation 12212   Technology Blvd. Austin TX 78727 USA2020-11-24 有效
77夾頭國械備20200674號Stryker   Instruments6201   South Sprinkle Road Portage, MI 490022020-11-24 有效
78拔牙鉗國械備20200673號Rite   Dent Manufacturing Company52-56   B Industrial Estate, Sialkot, 51340, Pakistan2020-11-23 有效
79刮治器國械備20151442號Hu-Friedy   Mfg.Co.,LLC3232   N. Rockwell Street, Chicago, IL 60618, United States2020-11-23 變更
80潔治器國械備20151437號Hu-Friedy   Mfg. Co., LLC3232   N. Rockwell Street, Chicago, IL 60618, United States2020-11-23 變更
81牙齒美白工具包國械備20200672號Discus   Dental LLC1700A   South Baker Avenue  Ontario, CA   91761  United States of America 2020-11-23 有效
82肱骨骨銼國械備20200671號VIANT   MEDICAL,LLC542   East 200 North Warsaw Indiana 46582 USA2020-11-23 有效
83咬骨鉗國械備20181360號Integra   LifeSciences Production CorporationLudwigstaler   Strasse 27, Postfach 4047, Tuttlingen Baden-Wurttemberg, GERMANY D-78532; 51   Dornierstrasse, Tuttlingen Baden-Wurttemberg, GERMANY 78532; Daimlerstrasse   15, Wurmlingen Baden-Wurttemberg, GERMANY D-785322020-11-23 變更
84槍形咬骨鉗國械備20190133號Integra   LifeSciences Production CorporationLehrstrasse   11, 78589 Dürbheim, DEUTSCHLAND; Hohnerstra?e 22, 78606 Seitingen-Oberflacht,   Deutschland; Uhlandstra?e 17, 78604 Rietheim-Weilheim, Deutschland;   Daimlerstra?e 15, 78573 Wurmlingen, Deutschland; Schlo??ckerweg 6/1, 78582   Balgheim, Germany2020-11-23 變更
85口腔科手術器械國械備20200670號SURGICRAFTSMuhammad   Pura，Commissioner Road，Sialkot,Pakistan2020-11-20 有效
86基礎外科手術器械國械備20200669號SURGICRAFTSMuhammad   Pura，Commissioner Road，Sialkot,Pakistan2020-11-20 有效
87刮匙國械備20200668號CM   Instrumente GmbH G?ns?cker   56，78532 Tuttlingen，Germany2020-11-20 有效
88CD4檢測試劑國械備20200667號Beckman   Coulter, Inc.740   West 83rd Street Hialeah, Florida 33014, USA2020-11-20 有效
89緩沖液國械備20140155號Beckman   Coulter, Inc.Mervue   Business Park, Galway, Ireland；2470 Faraday Avenue, Carlsbad, CA 92010, USA2020-11-20 變更
90緩沖液國械備20140188號Beckman   Coulter, Inc.Mervue   Business Park, Galway, Ireland；2470 Faraday Avenue, Carlsbad, CA 92010, USA2020-11-20 變更
91緩沖液國械備20151170號Beckman   Coulter, Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-20 變更
92樣本稀釋液國械備20170172號Beckman   Coulter, Inc.2470   Faraday, Carlsbad, CA92010, USA2020-11-20 變更
93全自動樣本處理系統(tǒng)國械備20151954號Beckman   Coulter, Inc.Sauerbruchstr.   50, 81377, Muenchen, Germany2020-11-20 變更
94樣本稀釋液國械備20151348號Beckman   Coulter, Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-20 變更
95樣本稀釋液國械備20151117號Beckman   Coulter, Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-20 變更
96造口袋國械備20181571號Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-20 變更
97緩沖液國械備20151166號Beckman   Coulter, Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-20 變更
98造口護理用品附件國械備20191252號Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2020-11-20 變更
99造口袋國械備20190948號Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2020-11-20 變更
100顯微剪 國械備20150504號Boss   Instruments, Ltd104   Sommerfield Drive,Gordonsville, VA229422020-11-19 變更
101CD8檢測試劑國械備20200666號Beckman   Coulter, Inc.740   West 83rd Street Hialeah, Florida 33014, USA2020-11-19 有效
102CD3檢測試劑國械備20200665號Beckman   Coulter, Inc.740   West 83rd Street Hialeah, Florida 33014, USA2020-11-19 有效
103同型對照抗體（小鼠IgG1）國械備20200664號Beckman   Coulter, Inc.740   West 83rd Street Hialeah, Florida 33014, USA2020-11-19 有效
104緩沖液國械備20170183號Beckman   Coulter Ireland Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-19 變更
105糖化血紅蛋白溶血劑國械備20170153號Beckman   Coulter, Inc.2470   Faraday, Carlsbad, CA 92010, USA2020-11-19 變更
106探針國械備20200663號CM   Instrumente GmbHG?ns?cker   56，78532 Tuttlingen, Germany2020-11-19 有效
107一次性使用牙科沖洗針國械備20200662號Produits   Dentaires SARue   des Bosquets 18, 1800 Vevey, Switzerland2020-11-19 有效
108造口灌洗器國械備20150307號Coloplast   A/SIndustrivej   7,7700 Thisted,Denmark2020-11-19 變更
109手術體位墊國械備20180304號Simonsen   & Weel A/SVardevej   9 DK-6740 Bramming Denmark；ul. Zeromskiego 20 PL-74 240 Lipiany Poland2020-11-18 變更
110樣本稀釋液國械備20181729號Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, Massachusetts 02032, USA2020-11-18 變更
111創(chuàng)口貼國械備20200661號curea   medical GmbHMünsterstra?e   61-65 48565 Steinfurt Deutschland2020-11-18 有效
112CD7檢測試劑國械備20200660號BIOLEGEND,   INC8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212020-11-17 有效
113CD45檢測試劑國械備20200658號BIOLEGEND,   INC8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212020-11-17 有效
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