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2024年2月國家局批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案73項(xiàng)
發(fā)布日期:2024-03-07 18:19瀏覽次數(shù):595次
來自國家藥監(jiān)局?jǐn)?shù)據(jù)，2024年2月，國家藥監(jiān)局批準(zhǔn)微孔板振蕩孵育器、全自動(dòng)核酸提取儀、造口皮膚保護(hù)劑、高分子固定繃帶、彈力繃帶、醫(yī)用檢查手套、呼吸訓(xùn)練器等，進(jìn)口第一類醫(yī)療器械產(chǎn)品備案73項(xiàng)，詳見正文。

來自國家藥監(jiān)局?jǐn)?shù)據(jù)，2024年2月，國家藥監(jiān)局批準(zhǔn)微孔板振蕩孵育器、全自動(dòng)核酸提取儀、造口皮膚保護(hù)劑、高分子固定繃帶、彈力繃帶、醫(yī)用檢查手套、呼吸訓(xùn)練器等，進(jìn)口第一類醫(yī)療器械產(chǎn)品備案73項(xiàng)，詳見正文。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2024年2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微孔板振蕩孵育器國械備20200372號(hào)Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2024-02-29 變更
2全自動(dòng)核酸提取儀國械備20140357號(hào)Wallac   OyMustionkatu   6, FI-20750 Turku, Finland2024-02-29 變更
3造口皮膚保護(hù)劑國械備20210611號(hào)康維德有限責(zé)任公司ConvaTec   LimitedUnit   12A&12B Kings Court，Prince William Avenue，Sandycroft，Deeside，CH5 2FG,   United Kingdom2024-02-29 變更
4高分子固定繃帶國械備20200440號(hào)ConvaTec   LimitedSt   Helens Road, Bolton, BL3 3PR, United Kingdom2024-02-29 變更
5彈力繃帶國械備20200388號(hào)ConvaTec   LimitedLowmoor   Business Park, Kirkby in Ashfield, Nottinghamshire, NG17 7JZ, UK.2024-02-29 變更
6造口皮膚保護(hù)劑國械備20210568號(hào)康維德有限責(zé)任公司ConvaTec   LimitedHickmans   Road, Birkenhead, Wirral CH41 1JH United Kingdom2024-02-29 變更
7醫(yī)用檢查手套國械備20240056號(hào)PT   . HALONI JANEJl.   Raya Serang Km. 13,8 Kawasan Industri Tristate, RT/RW 02/02, Desa Sukadamai,   Kec. Cikupa2024-02-29 有效
8牽開器國械備20220171號(hào)Rebstock   Instruments GmbHIn   Weiher?cker 7, 78589 Dürbheim Germany2024-02-29 變更
9牙科成形片套裝國械備20220355號(hào)Bioclear   Matrix Systems, LLC3802   S Warner Street Suite A Tacoma, WA US 984092024-02-29 變更
10顯微剪國械備20220161號(hào)Rebstock   Instruments GmbHIn   Weiher?cker 7, 78589 Dürbheim Germany2024-02-28 變更
11血管鉗國械備20220170號(hào)Rebstock   Instruments GmbHIn   Weiher?cker 7, 78589 Dürbheim Germany2024-02-28 變更
12手術(shù)刀柄國械備20150937號(hào)Swann-Morton   LimitedOwlerton   Green Sheffield S6 2BJ United Kingdom2024-02-28 變更
13手術(shù)刀片國械備20150431號(hào)Swann-Morton   LimitedOwlerton   Green Sheffield S6 2BJ United Kingdom2024-02-28 變更
14手術(shù)刀國械備20210404號(hào)Swann-Morton   LimitedOwlerton   Green Sheffield S6 2BJ United Kingdom2024-02-28 變更
15印模帽國械備20240055號(hào)BIOTEM   CO., LTD.422,   Sasang-ro, Sasang-gu, Busan-si, Republic of Korea2024-02-28 有效
16種植輔助材料國械備20190062號(hào)(?)??????   ??? ??? ???? 474 , 4? 411?, 4? 412? (????, ??????????)2024-02-27 變更
17種植體安裝輔助工具國械備20190673號(hào)(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2024-02-27 變更
18種植體螺絲起國械備20190674號(hào)(?)??????   ??? ???  ???? 474  , 4? 411?, 4? 412?(????, ??????????)2024-02-27 變更
19壓力繃帶國械備20150797號(hào)3M   Deutschland GmbH
2024-02-27 變更
20樣本萃取液國械備20240054號(hào)Abbott   Ireland Diagnostics Division940   Crossroads Blvd., Seguin, TX 78155 USA2024-02-27 有效
21牙科模型材料國械備20240053號(hào)delcone   inc.428-8,   Waryong-ro, Seo-gu, Daegu, Republic of Korea2024-02-26 有效
22髖關(guān)節(jié)手術(shù)器械國械備20151787號(hào)Smith   & Nephew,Inc1450   Brooks Road, Memphis, Tennessee, 38116, USA；
   
    Alemannenstraβe 14, D-78532, Tuttlingen, 78532, Germany;
   
    2 lengkok Teluk Kumbar 1, Jalan Teluk Kumbar, 11920 Bayan Lepas, Penang,   MALAYSIA;
   
    Schachenallee 29, 5001 Aarau, SWITZERLAND;
   
    Boulevard Héctor Terán #20120, Ciudad Industrial, Tijuana, B.C. 22444,   Mexico.
   
   		2024-02-26 變更
23膝關(guān)節(jié)手術(shù)器械國械備20160155號(hào)Smith   & Nephew, Inc./2024-02-26 變更
24輪轉(zhuǎn)式切片機(jī)國械備20160789號(hào)pfm   medical gmbhWankelstraβe   60  50996 K?ln, Germany2024-02-26 變更
25輪轉(zhuǎn)式切片機(jī)國械備20160787號(hào)pfm   medical gmbhWankelstraβe   60  50996 K?ln, Germany2024-02-26 變更
26輪轉(zhuǎn)式切片機(jī)國械備20160786號(hào)pfm   medical gmbhWankelstraβe   60  50996 K?ln, Germany2024-02-26 變更
27包埋機(jī)國械備20190921號(hào)pfm   medical gmbhWankelstra?e   60, 50996 K?ln, Germany2024-02-26 變更
28手動(dòng)推床國械備20161591號(hào)Stryker   Medical 3800   E. Centre Avenue Portage Michigan 49002 USA2024-02-23 變更
29婦產(chǎn)科診療床國械備20240052號(hào)Stryker   Medical3800   E. Centre Avenue Portage Michigan 49002 USA2024-02-23 有效
30吸引管國械備20240051號(hào)Surgivet   Instruments CompanyWazirabad   Road, Sialkot - Pakistan2024-02-22 有效
31牙科刮治器國械備20160969號(hào)PREMIER   DENTAL PRODUCTS CO.1710   Romano Dr. Plymouth Meeting, PA 194622024-02-22 變更
32牙探針國械備20160838號(hào)PREMIER   DENTAL PRODUCTS CO.1710   Romano Dr. Plymouth Meeting, PA 194622024-02-22 變更
33腰部固定器國械備20171027號(hào)Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115 Duderstadt,Germany2024-02-22 變更
34膝關(guān)節(jié)固定矯形器國械備20150274號(hào)Ottobock   SE & Co. KGaAMax   N?derStra?e 15 37115, Duderstadt,Germany2024-02-22 變更
35牙科用分離器國械備20240050號(hào)株式會(huì)社デンテック東京都板橋區(qū)清水町５３－５2024-02-22 有效
36牙科修整用鎢鋼車針國械備20200004號(hào)マニー株式會(huì)社栃木県塩谷郡高根沢町中阿久津743；   Tan Huong Commune, Pho Yen Town, Thai Nguyen Province, Vietnam2024-02-21 變更
37牙科修整用金剛砂車針國械備20240049號(hào)マニー株式會(huì)社①栃木県塩谷郡高根沢町中阿久津743②Vang   Residential Group, Tan Huong Ward, Pho Yen City, Thai Nguyen Province,   Vietnam2024-02-21 有效
38創(chuàng)口貼國械備20210144號(hào)NICO   MEDICAL CO., LTD.2579-2,   Baegok-daero, Mohyeon-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of   Korea 2024-02-21 無效
39創(chuàng)口貼國械備20210145號(hào)NICO   MEDICAL CO., LTD.2579-2,   Baegok-daero, Mohyeon-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, Republic of   Korea 2024-02-21 無效
40X射線防護(hù)裝置國械備20240048號(hào)MAVIG   GmbHStahlgruberring   5, 81829 Munich, Germany2024-02-20 有效
41替代體國械備20190919號(hào)Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2024-02-20 變更
42牙科種植體手術(shù)用工具國械備20160835號(hào)Biodenta   Swiss AGTramstr.   16 9442 Berneck Switzerland2024-02-20 變更
43醫(yī)用冰墊國械備20151006號(hào)璐瑪企業(yè)有限公司桃園縣新屋鄉(xiāng)九斗村中山東路二段255號(hào)2024-02-20 變更
44導(dǎo)引針國械備20200114號(hào)Search   Medical Co., Ltd.16,   Cheomdan venture so-ro 37 beon-gil, Buk-gu, Gwangju, Republic of Korea2024-02-20 變更
45牙科刮治器國械備20230040號(hào)PRODONT-HOLLIGER   part of ACTEON group3   La Marnasse, 63880 OLLIERGUES, FRANCE2024-02-19 變更
46電極導(dǎo)聯(lián)線國械備20220096號(hào)Natus   Neurology Incorporated3150   Pleasant View Road Middleton Wisconsin 53562 USA； IDA Business Park Gort Co.   Galway Ireland； 250 Okgucheondong-ro Siheung-si Gyeongi-do 15084 Republic of   Korea2024-02-19 變更
47緩沖液國械備20151545號(hào)Leica   Biosystems Newcastle Ltd3506   South Broadway Saint Louis MO 631182024-02-18 變更
48免疫組化稀釋液國械備20151840號(hào)Leica   Biosystems Newcastle Ltd3506   South Broadway, St Louis, MO 631182024-02-18 變更
49水槍頭國械備20171171號(hào)PRODUITS   DENTAIRES PIERRE ROLLAND SAS17   avenue Gustave Eiffel, Zone Industrielle du Phare, 33700 MERIGNAC FRANCE2024-02-08 變更
50CD123檢測試劑（流式細(xì)胞儀法)國械備20240047號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212024-02-07 有效
51CD123檢測試劑（流式細(xì)胞儀法）國械備20240046號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212024-02-07 有效
52快接頭國械備20240045號(hào)Synthes   GmbHEimattstrasse   3,4436 Oberdorf, Switzerland2024-02-07 有效
53醫(yī)用檢查手套國械備20200070號(hào)??????   ???? ?? ??? ????????????????? ?????112   ??????????? ??? 45 ???????, ???????, ?????, 901102024-02-06 變更
54全自動(dòng)微生物樣本處理系統(tǒng)國械備20210155號(hào)BD   Kiestra B.V.730   Fountain Street - Building 2, Cambridge, ON N3H 4R7, Canada2024-02-06 變更
55牙科醫(yī)師椅國械備20220259號(hào)CEFLA   S.C.VIA   BICOCCA 14/C-40026 IMOLA(BO)-ITALY2024-02-06 變更
56抗原修復(fù)緩沖液   BOND Epitope Retrieval Solution 1國械備20150328   號(hào)Leica   Biosystems Newcastle LtdSecond   Avenue, Heatherhouse Industrial Estate, Irvine, KA12 8NB, United Kingdom2024-02-05 變更
57清洗液   BOND Wash Solution 10X Concentrate國械備20150492號(hào)Leica   Biosystems Newcastle Ltd Second   Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12   8NB, United Kingdom2024-02-05 變更
58免疫顯色試劑   BOND Polymer Refine Detection國械備20150558號(hào)Leica   Biosystems Newcastle Ltd.Balliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2024-02-05 變更
59脫蠟液   BOND Dewax Solution國械備20140293號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2024-02-05 變更
60抗原修復(fù)緩沖液   BOND Epitope Retrieval Solution 2國械備20150327號(hào)Leica   Biosystems Newcastle LtdSecond   Avenue, Heather House Industrial Estate, Irvine, Ayrshire, Scotland, KA12   8NB, United Kingdom2024-02-05 變更
61原位雜交用蛋白酶   BOND Enzyme Pretreatment Kit國械備20150495號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2024-02-05 變更
62集尿袋 國械備20150559號(hào)ConvaTec   LimitedPriemyselny   Park 3, 07101 Michalovce, Slovakia2024-02-04 無效
63造口袋國械備20140099號(hào)ConvaTec   LimitedFirst   Avenue, Deeside Industrial Park, Deeside, Flintshire, CH5 2NU, United   Kingdom; Carretera Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buidings   23, 29, 30 Haina, San Cristobal 91000 Dominican Republic.2024-02-04 變更
64輪轉(zhuǎn)式切片機(jī)國械備20200279號(hào)pfm   medical gmbhWankelstr.   60, 50996 K?ln, Germany2024-02-04 變更
65牙墊國械備20210540號(hào)SigmaStim   Domestic LLC19799   S.W.95th Avenue Tualatin OR 97062 USA2024-02-04 變更
66髓過氧化物酶（MPO）檢測試劑   Anti-Myeloperoxydase-FITC國械備20180342號(hào)Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2024-02-04 變更
67髓過氧化物酶（MPO）檢測試劑   Anti-Myeloperoxydase-PE國械備20181294號(hào)Immunotech   S.A.S (a Beckman Coulter Company)130   Avenue de Lattre de Tassigny, BP 177 13276 Marseille Cedex 9, France 2024-02-04 變更
68創(chuàng)口貼國械備20200661號(hào)curea   medical GmbHMünsterstra?e   61-65 48565 Steinfurt Deutschland2024-02-04 變更
69創(chuàng)口貼國械備20210097號(hào)(?)?????????   ??? ???? ??? 142，3? 301?(???, ?????)2024-02-04 變更
70義眼片國械備20240044號(hào)Kunstaugeninstitut   Pro-Ocular Roland LautneBahnhofstra?e   2,90518 Altdorf,Deutschland2024-02-04 有效
71造口底盤國械備20200110號(hào)ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2024-02-02 變更
72呼吸訓(xùn)練器國械備20240043號(hào)貝斯美德股份有限公司新北市五股區(qū)五工二路116巷5號(hào) 2024-02-02 有效
73樣品后處理系統(tǒng)國械備20220396號(hào)醫(yī)全實(shí)業(yè)股份有限公司新北市五股區(qū)五權(quán)路   34 號(hào) 1 樓2024-02-01 變更

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