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2023年10月進口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2023-11-07 17:56瀏覽次數(shù):796次
來自國家藥監(jiān)局的數(shù)據(jù)，2023年10月國家藥監(jiān)局累計批準(zhǔn)進口第一類醫(yī)療器械產(chǎn)品備案事項62項，涵蓋了種植體安裝輔助器械、清洗液、口腔科手術(shù)器械、醫(yī)用冰墊、低速臺式離心機、造口袋等62個進口第一類器械醫(yī)療器械備案產(chǎn)品。詳見正文。

來自國家藥監(jiān)局的數(shù)據(jù)，2023年10月國家藥監(jiān)局累計批準(zhǔn)進口第一類醫(yī)療器械產(chǎn)品備案事項62項，涵蓋了種植體安裝輔助器械、清洗液、口腔科手術(shù)器械、醫(yī)用冰墊、低速臺式離心機、造口袋等62個進口第一類器械醫(yī)療器械備案產(chǎn)品。詳見正文。

進口第一類醫(yī)療器械產(chǎn)品備案.jpg

2023年10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種植體安裝輔助器械國械備20230513號Oneday   Biotech Co., Ltd.C-135,   Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea2023-10-31 有效
2種植輔助材料國械備20230512號Oneday   Biotech Co., Ltd.C-135,   Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea2023-10-31 有效
3牙科種植掃描體國械備20230511號Oneday   Biotech Co., Ltd.C-135,   Seongseodong-ro, Dalseo-gu, Daegu, Republic of Korea2023-10-31 有效
4清洗液國械備20230510號Siemens   Healthcare Diagnostics Inc.500   GBC Drive, P.O. Box 6101 Newark, DE, 19714, USA  2023-10-30 有效
5清洗液國械備20230509號Siemens   Healthcare Diagnostics Inc. Northern   Road, Chilton Industrial Estate, Sudbury, Suffolk CO10 2XQ, UK2023-10-30 有效
6口腔科手術(shù)器械國械備20230508號IBBI   DENTAL INSTRUMENTSHaji   Pura (Amba Wali Chapri) Near Dera Ch Ansar, Sialkot-Pakistan.2023-10-27 有效
7口腔科手術(shù)器械國械備20220065號Vitra   InternationalMarala   Road 51360,Sialkot-Pakistan2023-10-27 變更
8根管擴大器國械備20220106號株式會社背戸製作所茨城県つくば市小田4596の12023-10-27 變更
9醫(yī)用射線防護用品及裝置國械備20230507號Barrier   Technologies, LLC7060   W. State Rd 84, Suite 8, Davie, Florida, 33317, United States2023-10-25 有效
10自動加樣系統(tǒng)國械備20230506號シスメックス株式會社18735   Madrone Parkway Morgan Hill, CA 95037 United States of America2023-10-25 有效
11髖關(guān)節(jié)手術(shù)工具國械備20230505號Zimmer   Inc.1800   W. Center Street Warsaw Indiana 46580 USA2023-10-25 有效
12骨科牽引架國械備20230259號Allen   Medical Systems, Inc.100   Discovery Way Acton, MA 01720 USA2023-10-24 變更
13口腔科手術(shù)器械國械備20230504號TITAN   SURGICAL CO.Adalat   Ghara Nia,Sialkot-Pakistan2023-10-24 有效
14手術(shù)肌腱整理平臺國械備20200045號Arthrex,Inc.6875   Arthrex Commerce Drive Ave Maria, FL USA 34142 2023-10-23 變更
15細胞角蛋白（廣譜）抗體試劑（免疫組織化學(xué)）國械備20190048號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2023-10-23 變更
16清洗液國械備20230503號キヤノンメディカルシステムズ株式會社1359-1   Kagamida, Kigoshi, Gosen-shi, Niigata,959-1695 Japan2023-10-20 有效
17牙科種植工具包國械備20230502號Noris   Medical Ltd.8   Hataasia St., Nesher 36888082023-10-19 有效
18手術(shù)拉鉤國械備20150082號FEG   Textiltechnik Forschungs- und Entwicklungsgesellschaft mbHPrager   Ring 70, 52070 Aachen, Germany2023-10-19 變更
19醫(yī)用冰墊國械備20150159號彪仕醫(yī)技股份有限公司臺南市南區(qū)中華西路一段23號2023-10-19 無效
20低速臺式離心機國械備20230501號株式會社久保田製作所群馬県藤岡市中大塚1065-32023-10-19 有效
21低速冷凍離心機國械備20230500號株式會社久保田製作所群馬県藤岡市中大塚1065-32023-10-19 有效
22替代體國械備20230499號VIDA   DENTAL SAN. VE T?C. A.?.600   Evler Mah. Bal?kesir Asf. Sol Taraf Cad. ünallar Sitesi No: 10 Band?rma   BALIKES?R / TURKEY2023-10-19 有效
23免疫組化抗原修復(fù)緩沖液Novocastra   Epitope Retrieval Solution pH9國械備20160676號Leica   Biosystems Newcastle LtdSecond   Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12   8NB, United Kingdom2023-10-18 變更
24脫蠟液   BOND Dewax Solution國械備20140293號Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-10-18 變更
25免疫組化抗原修復(fù)緩沖液Novocastra   Epitope Retrieval Solution pH6國械備20160677號Leica   Biosystems Newcastle LtdSecond   Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12   8NB, United Kingdom2023-10-18 變更
26樣本稀釋液國械備20210596號富士レビオ株式會社日本國東京都八王子市小宮町51番地2023-10-18 變更
27樣本稀釋液國械備20160414號富士レビオ株式會社東京都八王子市小宮町51番地2023-10-18 變更
28全自動免疫檢驗系統(tǒng)用底物液國械備20160413號富士レビオ株式會社東京都八王子市小宮町５１番地2023-10-18 變更
29手術(shù)用動力手柄連接套管（帶參考架）國械備20230498號Medtronic   Powered Surgical Solutions4620   North Beach Street Fort Worth Texas 76137 USA2023-10-17 有效
30Gomori   三色染色液（綠）國械備20230497號Leica   Biosystems Richmond, Inc.5205   Route 12, P.O.Box 528, Richmond, Illinois 60071, USA2023-10-17 有效
31夾持鉗國械備20230496號FENTEXmedical   GmbHtake-off   Gewerbepark 2 78579 Neuhausen Ob Eck Germany2023-10-17 有效
32骨用牽開器國械備20230495號Thompson   Surgical Instruments, Inc.10341   E. Cherry Bend Road, Traverse City, MI, 49684 United States of America2023-10-17 有效
33Gomori   三色染色液（藍）國械備20230494號Leica   Biosystems Richmond, Inc.5205   Route 12, P.O.Box 528, Richmond, Illinois 60071, USA2023-10-17 有效
34組織固定液   O-FIX國械備20160444號Leica   Biosystems Richmond,Inc.5205   Route 12 P.O.Box 528 Richmond Illinois 60071 USA2023-10-17 變更
35染色機國械備20140016號Leica   Biosystems Melbourne Pty Ltd495   Blackburn Road Mt Waverley Victoria 3149 Australia2023-10-16 變更
36自動組織脫水機國械備20180309號Leica   Biosystems Melbourne Pty Ltd495   Blackburn Road, Mount Waverley, VIC3149, Australia2023-10-16 變更
37染色機國械備20140277號Leica   Biosystems Melbourne Pty Ltd495   Blackburn Road Mt Waverley Victoria 3149 Australia2023-10-16 變更
38過碘酸雪夫染色液國械備201619640號Leica   Biosystems Richmond, Inc.5205   Route 12 P.O. Box 528 Richmond Illinois 60071 USA2023-10-16 無效
39阿利辛藍－過碘酸雪夫氏染色液國械備20161937號Leica   Biosystems Richmond, Inc.5205   Route 12 P.O. Box 528 Richmond Illinois 60071 USA2023-10-16 無效
40醫(yī)用圖像打印機國械備20140244號/Max-Planck-Strasse   1, 82380 Peiβenberg, Germany2023-10-16 變更
41CD123檢測試劑（流式細胞儀法）國械備20230493號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-10-16 有效
42CD4檢測試劑國械備20230492號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-10-16 有效
43CD117檢測試劑國械備20210480號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-10-16 變更
44CD14檢測試劑國械備20230491號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-10-16 有效
45造口袋國械備20200543號Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary /Calle 58, Zona Franca La Lima, La Lima,   Guadalupe, 30106 Cartago, Costa Rica2023-10-13 變更
46二件式造口袋國械備20190784號Coloplast   A/SColoplast   Hungary KFT, Búzavirág út 15, 2800 Tatabánya, Hungary2023-10-13 變更
47橡皮障夾鉗國械備20230490號Secure   Dental CompanyNear   New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 – Pakistan2023-10-13 有效
48橡皮障支架國械備20230489號Secure   Dental CompanyNear   New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan2023-10-13 有效
49壓力繃帶國械備20171055號MAXIS   a.s.Francouzska   171/28, 12000 Praha 2 – Vinohrady, Czech Republic2023-10-13 變更
50FOXO1（13q14）基因斷裂探針試劑（熒光原位雜交法）國械備20230488號Kreatech   Biotechnology B.V. Vlierweg 20, 1032 LG Amsterdam, The   Netherlands2023-10-12 有效
51液體敷料國械備20190860號ConvaTec   LimitedUnits   12A & 12B kings Court, Prince William Avenue, Sandycroft, Deeside CH5   2FG, United Kingdom2023-10-12 無效
52脊柱手術(shù)器械國械備20210228號Synthes   GmbHIndustriestrasse   28, 2545 Selzach, Switzerland2023-10-12 變更
53脊柱微創(chuàng)手術(shù)工具包國械備20190164號Medos   International SARL50   Scotland Blvd, Bridgewater Massachusetts, 02324 USA2023-10-12 變更
54固定用彈力束帶國械備20181484號Bauerfeind   AGTriebeser   Straβe 16 07937 Zeulenroda- Triebes Germany2023-10-12 變更
55牙科手術(shù)器械包國械備20230487號AMMAR   INDUSTRIESNear   Ballanwala Post Office, Infront of Jamia Masjid Muhammadi Ahlayhadees,   Sialkot - Pakistan2023-10-12 有效
56緩沖液國械備20200682號RAL   DIAGNOSTICSSite   Montesquieu 33650 MARTILLAC FRANCE2023-10-12 變更
57橡皮障打孔器國械備20230486號Secure   Dental CompanyNear   New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan2023-10-12 有效
58橡皮障夾國械備20230485號Secure   Dental CompanyNear   New Ghalla Mandi, Main Aiman Abad Road, Sialkot - 51310 - Pakistan2023-10-12 有效
59自動加樣系統(tǒng)國械備20230484號Beckman   Coulter, Inc.11800   SW 147TH AVE Miami, FL USA 331962023-10-12 有效
60全自動免疫檢驗系統(tǒng)用底物液國械備20230483號Beckman   Coulter, Inc.1000   Lake Hazeltine Drive, Chaska, MN 55318-10842023-10-12 有效
61創(chuàng)口貼國械備20200613號//2023-10-12 變更
62牙科拋光磨頭國械備20230482號EVE   Ernst Vetter GmbHNeureutstr.6,   75210 Keltern, Germany2023-10-10 有效

如有進口第一類醫(yī)療器械產(chǎn)品備案代辦服務(wù)需求，歡迎您隨時方便與杭州證標(biāo)客醫(yī)藥技術(shù)咨詢有限公司聯(lián)絡(luò)，聯(lián)系人：葉工，電話：18058734169，微信同。

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