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口內(nèi)塑形刀等145個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案3月獲批
發(fā)布日期:2023-04-15 09:13瀏覽次數(shù):1523次
2023年4月14日，國家藥監(jiān)局發(fā)布《2023年3月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息》，口內(nèi)塑形刀等145個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案3月獲批。此外，特別需要關(guān)注的是，多個液體敷料的進(jìn)口第一類醫(yī)療器械產(chǎn)品備案撤銷。

2023年4月14日，國家藥監(jiān)局發(fā)布《2023年3月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息》，口內(nèi)塑形刀等145個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案3月獲批。此外，特別需要關(guān)注的是，多個液體敷料的進(jìn)口第一類醫(yī)療器械產(chǎn)品備案撤銷。

第一類醫(yī)療器械產(chǎn)品備案.jpg

2023年3月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息

2023年3月進(jìn)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口內(nèi)塑形刀國械備20230194號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2023-03-31 有效
2牙科用鑷國械備20230193號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2023-03-31 有效
3測序反應(yīng)通用試劑盒（測序法）國械備20180410號Illumina,   Inc.5200   Illumina Way, San Diego, California 92122, USA2023-03-31 變更
4耳鼻喉科手術(shù)器械國械備20230192號KARL   STORZ SE & Co. KG見附件22023-03-31 有效
5全自動微生物樣本處理系統(tǒng)國械備20180426號BD   Kiestra B.V.Building   #2, 730 Fountain Street, North Cambridge, Ontario N3H 4R7, Canada2023-03-30 變更
6藥敏接種培養(yǎng)液   BD PhoenixTM AST Broth國械備20150064號Becton,   Dickinson and Company250   Schilling Circle, Cockeysville, Maryland 21030 USA2023-03-30 變更
7尿液有形成分染色包國械備20181718號東洋紡株式會社福井県敦賀市東洋町10番24號2023-03-30 變更
8尿液分析用染色液國械備20180813號東洋紡株式會社10-24,   Toyo-cho, Tsuruga, Fukui, 914-8550 JAPAN2023-03-30 變更
9細(xì)胞計數(shù)板國械備20210519號東洋紡株式會社福井県敦賀市東洋町10番24號2023-03-30 變更
10固定器國械備20230191號Breg   Inc.CALZADA   PRESIDENTE VENUSTIANO CARRANZA #33 C.P.21385 MEXICALI Baja California,   MX         AVENIDA CIRCULO DE LA   AMISTAD #2701 PARQUE INDUSTRIAL PIMSA IV Mexicali Baja California, MX  212292023-03-30 有效
11頸椎前路鋼板系統(tǒng)手術(shù)工具包國械備20160953號Pioneer   Surgical technology,Inc.375   River Park Circle Marquette, Marquette, Michigan, 49855 USA2023-03-29 無效
12牽開器系統(tǒng)國械備20170239號Pioneer   Surgical technology,Inc.375   River Park Circle Marquette, Michigan, 49855 USA2023-03-29 無效
13頸椎前路鋼板系統(tǒng)手術(shù)工具包國械備20160647號Pioneer   Surgical technology,Inc.375   River Park Circle Marquette, Marquette, Michigan, 49855 USA2023-03-29 無效
14刀片夾持器國械備20180109號Pioneer   Surgical technology,Inc.375   RIVER PARK CIRCLE Marquette, MI USA 498552023-03-28 無效
15下肢醫(yī)用外固定支具國械備20150418號Breg   Inc.Calzada   Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California,   Mexico2023-03-28 變更
16上肢醫(yī)用外固定支具國械備20150417號Breg   Inc.Calzada   Presidnte Venustiano Carrnza #33, C.P.21385, Mexicali, Baja California,   Mexico2023-03-28 變更
17醫(yī)用外固定支具國械備20180274號Breg   IncCalzada   Presidnte Venustiano Carrnza #33, C.p.21385, Mexicali, Baja California,   Mexico.2023-03-28 變更
18CD71檢測試劑國械備20230190號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-03-28 有效
19CD45RA檢測試劑國械備20230189號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-03-28 有效
20CD62P檢測試劑國械備20230188號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-03-28 有效
21CD62P檢測試劑國械備20230187號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-03-28 有效
22口腔隔離器具國械備20170181號(?)??42-25,   Dongsan-Ro 27beon-gil, Danwon-gu, Ansan-si, Gyeonggi-do, Korea Rep.2023-03-28 變更
23PTEN抗體試劑（免疫組織化學(xué)）國械備20180434號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2023-03-28 變更
24CD30抗體試劑（免疫組織化學(xué)）國械備20181037號Ventana   Medical Systems,Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2023-03-28 變更
25細(xì)胞角蛋白20抗體試劑（免疫組織化學(xué)） 國械備20190049號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2023-03-28 變更
26SOX-10   抗體試劑（免疫組織化學(xué)法）國械備20230186號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin CA 95677 USA2023-03-28 有效
27液體敷料國械備20210279號Dr.Korman   Laboratories Ltd.23   Yosef Levi Str. Kiryat Bialik, 2751123 Israel2023-03-28 無效
28液體敷料國械備20210280號Dr.Korman   Laboratories Ltd.23   Yosef Levi Str. Kiryat Bialik, 2751123 Israel2023-03-28 無效
29種植輔助材料國械備20230185號Medigma   Biomedical GmbHSiemensstra?e   10 78564 Wehingen Germany2023-03-27 有效
30種植安裝輔助工具國械備20230184號Medigma   Biomedical GmbHSiemensstra?e   10 78564 Wehingen Germany2023-03-27 有效
31顱骨固定與修復(fù)手術(shù)器械 國械備20180687號Synthes   GmbH見附件。2023-03-27 變更
32骨科手術(shù)器械國械備20230183號Arthrex,   Inc.6875   Arthrex Commerce Drive Ave Maria Florida 34142 USA; Württemberger Stra?e 26   78567 Fridingen Germany2023-03-27 有效
33牙科用刀國械備20152064號ASA   DENTAL S.p.A.Via   Valenzana, 60-55054 Bozzano (LU) -Italy2023-03-27 變更
34胸腔心血管外科手術(shù)器械國械備20191358號Medical   Device Development GmbH Steig?cker   20 ,78582 Balgheim,Germany2023-03-24 變更
35胸腔心血管外科手術(shù)器械國械備20200391號CM   Instrumente GmbH G?ns?cker   56，78532 Tuttlingen, Germany2023-03-24 變更
36牙周探針國械備20230182號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2023-03-24 有效
37牙用充填器國械備20230181號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2023-03-24 有效
38牙科用鑷國械備20161892號株式會社YDM埼玉県東松山市今泉28番地 2023-03-24 變更
39牙科用剪國械備20170030   號株式會社YDM埼玉県東松山市今泉28番地 2023-03-24 變更
40牙科去冠器  國械備20170715    號株式會社YDM埼玉県東松山市今泉28番地 2023-03-24 變更
41拔牙鉗國械備20170565號株式會社YDM埼玉県東松山市今泉28番地2023-03-24 變更
42組織鉗國械備20160466號CM   Instrumente GmbH  G?ns?cker   56，78532 Tuttlingen，Germany2023-03-24 變更
43牽開器國械備20200687號CM   Instrumente GmbH  G?ns?cker   56，78532 Tuttlingen，Germany2023-03-24 變更
44顯微剪國械備20150399號CM   Instrumente GmbH  G?ns?cker   56 D-78532 Tuttlingen2023-03-24 變更
45顯微鑷國械備20200627號//2023-03-24 變更
46拔牙鉗國械備20151607號LASCOD   S.P.A. (LABORATORI SCIENTIFICI ODONTOIATRIA)IT-50019   SESTO FIORENTINO (FI)-VIA L.LONGO, 182023-03-23 變更
47正畸鉗國械備20151613號LASCOD   S.P.A. (LABORATORI SCIENTIFICI ODONTOIATRIA)IT-50019   SESTO FIORENTINO (FI)-VIA L.LONGO, 182023-03-23 變更
48銀汞合金充填器國械備20230180號PRODONT-HOLLIGER   SOCIETE PAR ACTIONS SIMPLIFIEELieu-dit   La Marnasse,63880 Olliergues,France2023-03-23 有效
49種植體植入手術(shù)器械包國械備20170276號Zimmer   Dental, Inc.1900   Aston Avenue, Carlsbad, CA 92008, USA2023-03-23 變更
50骨科用鋸片國械備20200509號W&H   Dentalwerk Bürmoos GmbHAlkuinstrasse   15, 48155 Münster, GERMANY2023-03-23 變更
51超聲潔牙機(jī)工作尖國械備20190254號W&H   Dentalwerk Bürmoos GmbHIgnaz-Glaser-Straβe   53, 5111 Bürmoos, Austria2023-03-23 變更
52人工耳蝸手術(shù)工具包國械備20181710號Advanced   Bionics LLC28515   Westinghouse Pl, Valencia, CA 91355; 12740 San Fernando Rd, Sylmar, CA 913422023-03-22 變更
53樣本稀釋液國械備20230179號東ソー株式會社日本國富山県富山市巖瀬古志町2番地2023-03-22 有效
54造口腰帶國械備20230178號Hollister   IncorporatedSEI   Medical S.A. de C.V Roberto Fierro #6420 & Francisco Sarabia Parque   Industrial Aeropuerto Juarez, Chihuahua,    MEXICO 326852023-03-22 有效
55痰消化液國械備20140121號Oxoid   LimitedWade   Road, Basingstoke, RG24 8PW, Untied Kingdom2023-03-22 變更
56牙挺國械備20151608號LASCOD   S.P.A. (LABORATORI SCIENTIFICI ODONTOIATRIA)IT-50019   SESTO FIORENTINO (FI)-VIA L.LONGO, 182023-03-21 變更
57牙用充填器國械備20151612號LASCOD   S.P.A. (LABORATORI SCIENTIFICI ODONTOIATRIA)IT-50019   SESTO FIORENTINO (FI)-VIA L.LONGO, 182023-03-21 變更
58蘇木素-伊紅染色液（H-E）國械備20230176號Leica   Biosystems Richmond, Inc.5205   Route 12 P.O. Box 528 Richmond Illinois 60071 USA2023-03-21 有效
59蘇木素-伊紅染色液（H-E）國械備20230175號Leica   Biosystems Richmond, Inc.5205   Route 12 P.O. Box 528 Richmond Illinois 60071 USA2023-03-21 有效
60樣本稀釋液國械備20230174號シスメックス株式會社兵庫県神戸市西區(qū)高塚臺4丁目3番地22023-03-21 有效
61醫(yī)用檢查手套國械備20170681號Sri   Trang Gloves (Thailand) Public Company Limited109/2   Kanjanavanit Road, Pahtong, Hatyai, Songkhla 90230, Thailand2023-03-21 變更
62頭戴式檢查燈國械備20191320號//2023-03-21 變更
63超聲探頭穿刺架國械備20180216號CIVCO   Medical Instruments Co.,Inc.102   FIRST ST.SOUTH Kalona, IA USA 522472023-03-21 變更
64Mammaglobin抗體試劑（免疫組織化學(xué)）BOND   Ready-to-Use Primary Antibody Mammaglobin (EP249)國械備20190014號Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-03-20 變更
65CD103抗體試劑（免疫組織化學(xué)法）國械備20191113號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-03-20 變更
66p120抗體試劑（免疫組織化學(xué)）   BOND Ready-to-Use Primary Antibody p120 Catenin (EP66)國械備20190013號Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-03-20 變更
67PMS2抗體試劑（免疫組織化學(xué)）國械備20210586號 Leica Biosystems Newcastle Ltd Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-03-20 變更
68CD43抗體試劑（免疫組織化學(xué)）國械備20190634號Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-03-20 變更
69Human   Growth Hormone抗體試劑（免疫組織化學(xué)）國械備20190631號Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-03-20 變更
70CA   19-9抗體試劑（免疫組織化學(xué)） BOND Ready-to-Use Primary Antibody CA19-9 (Sialyl   Lewis<sup>a</sup>) (C241:5:1:4)國械備20190006號Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-03-20 變更
71MSH6抗體試劑（免疫組織化學(xué)）國械備20210599號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-03-20 變更
72口鏡國械備20230173號ASA   DENTAL SPAVIA   FIERLA 13-33085 MANIAGO (PN)2023-03-20 有效
73細(xì)胞角蛋白8&18抗體試劑（免疫組織化學(xué)）國械備20190565號Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-03-17 變更
74Galectin-3抗體試劑（免疫組織化學(xué)）   BOND Ready-to-Use Primary Antibody Galectin-3 (9C4)國械備20190197號Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-03-17 變更
75凝血因子（Factor）XIIIa抗體試劑（免疫組織化學(xué)法）國械備20191346號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom　2023-03-17 變更
76脊柱用手術(shù)工具國械備20230172號Medtronic   Sofamor Danek USA, Inc.8347   N Steven Road, Milwaukee WI 53223, USA2023-03-17 有效
77止血鉗國械備20151959號CM   Instrumente GmbH Gansacker   56 D-78532 Tuttlingen2023-03-17 變更
78顯微鑷國械備20230171號Aesculap   AG見附件2023-03-16 有效
79髖關(guān)節(jié)手術(shù)工具國械備20230170號Howmedica   Osteonics CorpIDA   Industrial Estate, Carrigtwohill, County Cork, Ireland2023-03-16 有效
80固定用彈力束帶國械備20230169號 Bauerfeind AGTriebeser   Stra?e 16 07937 Zeulenroda-Triebes Germany2023-03-16 有效
81膝部固定帶國械備20230168號Bauerfeind   AGTriebeser   Stra?e 16 07937 Zeulenroda-Triebes Germany2023-03-16 有效
82牽開器國械備20230167號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-03-16 有效
83耳鼻喉用撐開器國械備20230166號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-03-16 有效
84鼻窺器國械備20230165號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-03-16 有效
85造口袋國械備20210159號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2023-03-16 變更
86髖關(guān)節(jié)手術(shù)工具國械備20230164號MAKO   Surgical Corp.273   North Pike Road Sarver, PA 160552023-03-15 有效
87CD38檢測試劑國械備20230163號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-03-15 有效
88CD45RO檢測試劑國械備20230162號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-03-15 有效
89CD103檢測試劑國械備20230161號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-03-15 有效
90CD103檢測試劑國械備20230160號BioLegend,   Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-03-15 有效
91彈力套國械備20230159號Medical   Z14   rue Georges Cuvier 37550 Saint-Averitn2023-03-14 有效
92軟管連接件國械備20230158號株式會社ナカニシ日本栃木県鹿沼市下日向7002023-03-14 有效
93口腔科技工室用拋光保護(hù)帽國械備20210009號Biomet   3i（1）4555   Riverside Drive, Palm Beach Gardens, Florida 33410,USA； （2）C/Islas Baleares,   50 Pol. Ind. Fuente de Jarro Paterna , Valencia 46988 Spain2023-03-14 變更
94增強液國械備20200322號DiaSorin   Italia S.p.A.Von-Hevesy-Str.   3, 63128 Dietzenbach, Germany2023-03-14 變更
95鼻骨銼國械備20230157號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck 2023-03-14 有效
96扁桃體圈斷器國械備20230156號Berger   Surgical Medical Products GmbHTake-off-Gewerbepark   4 D-78579 Neuhausen ob Eck2023-03-14 有效
97骨科電鉆頭國械備20230155號Hager   & Meisinger GmbHHansemannstr.   10, 41468 Neuss, Germany2023-03-13 有效
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99樣本稀釋液國械備20151941號EUROIMMUN   Medizinische Labordiagnostika AGSeekamp   31, D-23560 Lübeck, Germany2023-03-10 變更
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