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2020年11月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2021-01-03 13:54瀏覽次數(shù):5067次
近日,藥監(jiān)總局發(fā)布2020年11月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息,共計(jì)226個(gè)進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品完成備案。

引言:近日,藥監(jiān)總局發(fā)布2020年11月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息,共計(jì)226個(gè)進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品完成備案。

醫(yī)療器械產(chǎn)品備案.jpg

2020年11月進(jìn)口第一類(lèi)醫(yī)療器械產(chǎn)品備案信息

序號(hào)產(chǎn)品名稱(chēng)備案號(hào)備案人名稱(chēng)原文生產(chǎn)地址原文備案日期狀態(tài)
1球囊擴(kuò)張充壓裝置國(guó)械備20200689號(hào)株式會(huì)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(shù)工具包國(guó)械備20200688號(hào)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(guó)械備20181569號(hào)Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-30 變更
4造口底盤(pán)國(guó)械備20190932號(hào)Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2020-11-30 變更
5造口護(hù)理用品國(guó)械備20181590號(hào)Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-30 變更
6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
2020-11-27 變更
7牽開(kāi)器國(guó)械備20200687號(hào)CM   Instrumente GmbH  G?ns?cker   56,78532 Tuttlingen,Germany2020-11-27 有效
8種植體掃描體國(guó)械備20161179號(hào)DIO   Corporation66,   Centumseo-ro, Haeundae-gu, Busan, REPUBLIC OF KOREA2020-11-27 變更
9造口皮膚保護(hù)膜國(guó)械備20190111號(hào)Coloplast   A/STeampac   Oy, Dunkatie 4, 07880 Liljendal, Finland2020-11-27 變更
10造口袋國(guó)械備20181653號(hào)Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-27 變更
11測(cè)瓣器套裝國(guó)械備20150500號(hào)Edwards   Lifesciences LLCOne   Edwards Way Irvine, CA 926142020-11-27 變更
12二件式造口袋國(guó)械備20190784號(hào)Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-27 變更
13造口皮膚保護(hù)劑國(guó)械備20191410號(hào)Coloplast   A/Sul.Szczakowska   35, 43-600 Jaworzno, Poland2020-11-27 變更
14醫(yī)用圖像打印機(jī)國(guó)械備20200686號(hào)Agfa   NVMax-Planck-Str.   1, 82380, Peiβenberg, Germany2020-11-26 有效
15牙科磷酸鹽鑄造包埋材國(guó)械備20200685號(hào)SRL   Dental GmbHGiulinistra?e   2 67065 Ludwigshafen Germany2020-11-26 有效
16機(jī)動(dòng)基臺(tái)螺絲起國(guó)械備20200684號(hào)TALLADIUM   ESPA?A, S.L.C/VIRGINIA   WOOLF 17-25005 LLEIDA SPAIN2020-11-26 有效
17血細(xì)胞分析用染色液國(guó)械備20200683號(hào)RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2020-11-26 有效
18緩沖液國(guó)械備20200682號(hào)RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2020-11-26 有效
19骨測(cè)量器國(guó)械備20152049   號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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2020-11-25 變更
20骨錐 國(guó)械備20152024號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
21固定針國(guó)械備20152047號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY
2020-11-25 變更
22骨科定位片 國(guó)械備20152031號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
23打入器國(guó)械備20152032號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY
2020-11-25 變更
24 骨拉鉤國(guó)械備20152012號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
25打拔器國(guó)械備20152033號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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26峨眉鑿國(guó)械備20151880號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg Germany2020-11-25 變更
27口腔科手術(shù)器械國(guó)械備20200681號(hào)ASAS   AND BROTHERS ENTERPRISESModel   Town,Ugoki,Sialkot,Pakistan2020-11-25 有效
28骨撬國(guó)械備20152018號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
29試色糊劑國(guó)械備20190250號(hào)Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, Liechtenstein2020-11-25 變更
30骨刮匙國(guó)械備20152020號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
31夾持器國(guó)械備20152021號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
32鋼絲穿引器國(guó)械備20152023號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
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33骨銼國(guó)械備20152019號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY
   
   
2020-11-25 變更
34吉姆薩染色液國(guó)械備20140176號(hào)Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA2020-11-25 變更
35血細(xì)胞分析用溶血?jiǎng)?nbsp;國(guó)械備20161504號(hào)Beckman   Coulter, Inc.Parc   Euromedicine-Rue du Caducee, BP 7290, 34184 Montpellier Cedex 4, France2020-11-25 變更
36血細(xì)胞分析用染色液國(guó)械備20161505號(hào)Beckman   Coulter, Inc.Parc   Euromedicine-Rue du Caducee, BP 7290, 34184 Montpellier Cedex 4, France2020-11-25 變更
37血細(xì)胞分析用染色液國(guó)械備20170266號(hào)Beckman   Coulter, Inc.7381   Empire Drive, Florence, KY 41042, USA2020-11-25 變更
38緩沖液國(guó)械備20140233號(hào)Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA2020-11-25 變更
39緩沖液國(guó)械備20140237號(hào)Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA2020-11-25 變更
40瑞氏-吉姆薩染色液國(guó)械備20140179號(hào)Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA2020-11-25 變更
41瑞氏染色液國(guó)械備20140187號(hào)Beckman   coulter, Inc.400   Valley Road Warrington, Pennsylvania 18976 USA 2020-11-25 變更
42血細(xì)胞分析用染色液國(guó)械備20170213號(hào)Beckman   Coulter, Inc.740   W 83rd Street, Hialeah, FL 33014, USA2020-11-25 變更
43血細(xì)胞分析用稀釋液國(guó)械備20140159號(hào)Beckman   coulter, Inc.7381   Empire Drive, Florence, Kentucky 41042, USA2020-11-25 變更
44血細(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20140184號(hào)Beckman   coulter, Inc.7381   Empire Drive, Florence, Kentucky 41042, USA2020-11-25 變更
45血細(xì)胞分析用染色液國(guó)械備20151293號(hào)Beckman   coulter, Inc.7381   Empire Drive, Florence, Kentucky 41042, USA2020-11-25 變更
46全自動(dòng)推片染片系統(tǒng)國(guó)械備20160725號(hào)Beckman   Coulter, Inc.11800   SW 147th Ave., Miami, FL 33196 USA2020-11-25 變更
47測(cè)瓣器國(guó)械備20200680號(hào)St.   Jude Medical177   County Road B East St. Paul Minnesota 55117 USA2020-11-25 有效
48截骨板國(guó)械備20152139號(hào)Waldemar   Link GmbH & Co. KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
49髖臼銼國(guó)械備20152138號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
50填充塊國(guó)械備20152137號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
51尿液分析用鞘液   iQ? LaminaTM國(guó)械備20150059號(hào)Beckman   Coulter Ireland Inc.7381   Empire Drive, Florence, Kentucky 41042, USA2020-11-25 變更
52髓腔銼國(guó)械備20152136號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
53清洗液   iChem? VELOCITY(TM) Wash Solution國(guó)械備20140183號(hào)Beckman   Coulter Ireland Inc. 2470   Faraday Avenue Carlsbad CA 92010 USA2020-11-25 變更
54鋼絲鉗國(guó)械備20152043號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
55扳手國(guó)械備20152042號(hào) Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY
2020-11-25 變更
56體液分析用溶血?jiǎng)?  iQ? Body Fluids Lysing Reagent 國(guó)械備20150226號(hào)Beckman   Coulter Ireland Inc.2470   Faraday Avenue Carlsbad, CA 92010 USA2020-11-25 變更
57導(dǎo)鉆 國(guó)械備20152045號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
58血細(xì)胞分析用稀釋液國(guó)械備20180178號(hào)Beckman   Coulter Ireland Inc. Europark Fichtenhain B13, 47807 Krefeld,   Germany 2020-11-25 變更
59拔出器 國(guó)械備20152044號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg
   
    GERMANY
2020-11-25 變更
60血細(xì)胞分析用染色液國(guó)械備20200679號(hào)RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2020-11-25 有效
61骨用牽開(kāi)器國(guó)械備20152127號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
62取出鉗國(guó)械備20152126號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
63血細(xì)胞分析用溶血?jiǎng)?/td>國(guó)械備20180180號(hào) 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(guó)械備20152129號(hào)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(guó)械備20140182號(hào)Beckman   Coulter Ireland Inc.2470   Faraday Avenue Carlsbad CA 92010 USA2020-11-25 變更
66血細(xì)胞分析用染色液國(guó)械備20200678號(hào)RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2020-11-25 有效
67快裝手柄國(guó)械備20152128號(hào)Waldemar   Link GmbH & Co. KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
68髓腔鉸刀國(guó)械備20152135號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
69扭斷器國(guó)械備20152130號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2020-11-25 變更
70自動(dòng)樣本處理系統(tǒng)國(guó)械備20150277號(hào)Beckman   Coulter, Inc.8-14-30   Nagaminehigashi, Higashi-ku, Kumamoto-shi, Kumamoto-ken Japan2020-11-25 變更
71全自動(dòng)樣品處理系統(tǒng)國(guó)械備20181379號(hào)Beckman   Coulter Biomedical GmbHRupert-Mayer-Strasse   44 Muenchen 81379 Germany2020-11-25 變更
72自動(dòng)樣本處理系統(tǒng)國(guó)械備20151466號(hào)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(shù)工具國(guó)械備20170832號(hào)bricon   GmbHVillingerstr.   33 78166 Donaueschingen Germany2020-11-24 變更
74骨刀國(guó)械備20200677號(hào)CM   Instrumente GmbH  G?ns?cker   56,78532 Tuttlingen,Germany2020-11-24 有效
75鞘液濃縮液國(guó)械備20200676號(hào)Luminex   Corporation12212   Technology Blvd. Austin TX 78727 USA2020-11-24 有效
76鞘液國(guó)械備20200675號(hào)Luminex   Corporation 12212   Technology Blvd. Austin TX 78727 USA2020-11-24 有效
77夾頭國(guó)械備20200674號(hào)Stryker   Instruments6201   South Sprinkle Road Portage, MI 490022020-11-24 有效
78拔牙鉗國(guó)械備20200673號(hào)Rite   Dent Manufacturing Company52-56   B Industrial Estate, Sialkot, 51340, Pakistan2020-11-23 有效
79刮治器國(guó)械備20151442號(hào)Hu-Friedy   Mfg.Co.,LLC3232   N. Rockwell Street, Chicago, IL 60618, United States2020-11-23 變更
80潔治器國(guó)械備20151437號(hào)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(guó)械備20200672號(hào)Discus   Dental LLC1700A   South Baker Avenue  Ontario, CA   91761  United States of America 2020-11-23 有效
82肱骨骨銼國(guó)械備20200671號(hào)VIANT   MEDICAL,LLC542   East 200 North Warsaw Indiana 46582 USA2020-11-23 有效
83咬骨鉗國(guó)械備20181360號(hào)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(guó)械備20190133號(hào)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(shù)器械國(guó)械備20200670號(hào)SURGICRAFTSMuhammad   Pura,Commissioner Road,Sialkot,Pakistan2020-11-20 有效
86基礎(chǔ)外科手術(shù)器械國(guó)械備20200669號(hào)SURGICRAFTSMuhammad   Pura,Commissioner Road,Sialkot,Pakistan2020-11-20 有效
87刮匙國(guó)械備20200668號(hào)CM   Instrumente GmbH G?ns?cker   56,78532 Tuttlingen,Germany2020-11-20 有效
88CD4檢測(cè)試劑國(guó)械備20200667號(hào)Beckman   Coulter, Inc.740   West 83rd Street Hialeah, Florida 33014, USA2020-11-20 有效
89緩沖液國(guó)械備20140155號(hào)Beckman   Coulter, Inc.Mervue   Business Park, Galway, Ireland;2470 Faraday Avenue, Carlsbad, CA 92010, USA2020-11-20 變更
90緩沖液國(guó)械備20140188號(hào)Beckman   Coulter, Inc.Mervue   Business Park, Galway, Ireland;2470 Faraday Avenue, Carlsbad, CA 92010, USA2020-11-20 變更
91緩沖液國(guó)械備20151170號(hào)Beckman   Coulter, Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-20 變更
92樣本稀釋液國(guó)械備20170172號(hào)Beckman   Coulter, Inc.2470   Faraday, Carlsbad, CA92010, USA2020-11-20 變更
93全自動(dòng)樣本處理系統(tǒng)國(guó)械備20151954號(hào)Beckman   Coulter, Inc.Sauerbruchstr.   50, 81377, Muenchen, Germany2020-11-20 變更
94樣本稀釋液國(guó)械備20151348號(hào)Beckman   Coulter, Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-20 變更
95樣本稀釋液國(guó)械備20151117號(hào)Beckman   Coulter, Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-20 變更
96造口袋國(guó)械備20181571號(hào)Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2020-11-20 變更
97緩沖液國(guó)械備20151166號(hào)Beckman   Coulter, Inc.Lismeehan   O'Callaghan's Mills Co. Clare Ireland2020-11-20 變更
98造口護(hù)理用品附件國(guó)械備20191252號(hào)Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2020-11-20 變更
99造口袋國(guó)械備20190948號(hào)Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2020-11-20 變更
100顯微剪 國(guó)械備20150504號(hào)Boss   Instruments, Ltd104   Sommerfield Drive,Gordonsville, VA229422020-11-19 變更
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