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2022年1月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2022-02-26 00:00瀏覽次數(shù):3434次
2022年1月，國家藥監(jiān)局共計(jì)批準(zhǔn)116個(gè)進(jìn)口第一類醫(yī)療器械備案產(chǎn)品，一起來看看這些有臨床應(yīng)用價(jià)值的產(chǎn)品。

2022年1月，國家藥監(jiān)局共計(jì)批準(zhǔn)116個(gè)進(jìn)口第一類醫(yī)療器械備案產(chǎn)品，一起來看看這些有臨床應(yīng)用價(jià)值的產(chǎn)品。

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牙科石膏國械備20190226號(hào)Garreco,   LLC430   Hiram Road Heber Springs Arkansas 72543 USA2022-01-30 變更
2種植體安裝用工具國械備20170992號(hào)Neoss   ABWindsor   House, Cornwall Road, Harrogate, HG1 2PW, United Kingdom2022-01-28 變更
3種植輔助材料 國械備20220029號(hào)ADIN   DENTAL IMPLANT SYSTEMS LTD.Industrial   Zone Alon Tavor, POB 1128 Afula, 1811101 Israel2022-01-28 有效
4種植體掃描體國械備20181459號(hào)Neoss   ABWindsor   House, Cornwall Road, Harrogate, HG1 2PW, United Kingdom2022-01-27 變更
5牙科種植輔助工具國械備20181693號(hào)Neoss   ABWindsor   House, Cornwall Road, Harrogate, HG1 2PW, United Kingdom2022-01-27 變更
6檢查手套國械備20161722號(hào)TG   MEDICAL SDN. BHD.Lot   5091, Jalan Teratai, Batu 5, off Jalan Meru, 41050 Klang, Selangor Darul   Ehsan2022-01-27 變更
7檢查手套國械備20160795號(hào)Top   Glove Sdn. Bhd.Lot   4969, Jalan Teratai, Batu 6, Off Jalan Meru, 41050 Klang, Selangor D. E.,   MALAYSIA2022-01-27 變更
8檢查手套國械備20180322號(hào)Top   Glove Sdn. Bhd.Lot   4969, Jalan Teratai Batu 6 Off Jalan Meru 41050 Klang, Selangor D.E. MALAYSIA2022-01-27 變更
9牙科種植用延長器國械備20191421號(hào)Osstem   Implant Co.,Ltd.66-16,   Bansong-ro, 513beon-gil, Haeundae-gu, Busan, korea2022-01-27 變更
10全自動(dòng)核酸提取儀國械備20220028號(hào)Life   Technologies Holdings Pte LtdBlock   33 Marsiling Industrial Estate Road 3, #07-06 Singapore 7392562022-01-26 有效
11鼻氧管國械備20160397號(hào)太平洋醫(yī)材股份有限公司苗栗縣銅鑼鄉(xiāng)自強(qiáng)路19號(hào)2022-01-26 變更
12氧氣面罩國械備20160849號(hào)太平洋醫(yī)材股份有限公司苗栗縣銅鑼鄉(xiāng)自強(qiáng)路19號(hào)2022-01-26 變更
13生物顯微鏡國械備20220027號(hào) Leica Microsystems CMS GmbHErnst-Leitz-Stra?e   17-37,35578 Wetzlar, GERMANY2022-01-24 有效
14生物顯微鏡國械備20220026號(hào)Leica   Microsystems CMS GmbHErnst-Leitz-Stra?e   17-37,35578 Wetzlar, GERMANY2022-01-24 有效
15膝部固定器國械備20220025號(hào)豐利國際股份有限公司南投縣南投市福興里永興路13號(hào)2、3樓2022-01-21 有效
16咬合紙國械備20180191號(hào)Harald   Nordin SAZone   Industrielle La Foge,CH-1816 Chailly-sur-Montreux, Switzerland2022-01-21 變更
17集尿袋國械備20162035號(hào)太平洋醫(yī)材股份有限公司苗栗縣銅鑼鄉(xiāng)自強(qiáng)路19號(hào) 2022-01-21 變更
18口腔抽吸管（含刷頭）國械備20160537號(hào)太平洋醫(yī)材股份有限公司苗栗縣銅鑼鄉(xiāng)自強(qiáng)路19號(hào)2022-01-21 變更
19創(chuàng)口貼國械備20151101號(hào) 東洋化學(xué)株式會(huì)社滋賀縣蒲生郡日野町寺尻1008番地2022-01-21 變更
20基礎(chǔ)外科用刀國械備20220024號(hào)SGS   EXPORT INTERNATIONALRoras   Road, P.O. Box 1281, Sialkot-51310 - Pakistan2022-01-20 有效
21手術(shù)剪國械備20220023號(hào)Beauty   Teck International (Pvt) Ltd.Head   Marala Road, Machi Khokar, Sialkot 51310, Pakistan2022-01-20 有效
22組織鑷國械備20220022號(hào)Beauty   Teck International (Pvt) Ltd.Head   Marala Road, Machi Khokar, Sialkot 51310, Pakistan2022-01-20 有效
23組織鉗國械備20220021號(hào)Beauty   Teck International (Pvt) Ltd.Head   Marala Road, Machi Khokar, Sialkot 51310, Pakistan2022-01-20 有效
24頭燈國械備20160035號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
25吸引管國械備20160141號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
26醫(yī)用檢查音叉國械備20171244號(hào)RZ   Medizintechnik GmnHUnter   Hasslen 20 78532 Tuttlingen Germany2022-01-20 變更
27鉤針國械備20160033號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
28骨錘國械備20160030號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
29顯微鑷國械備20170009號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
30口腔開口器國械備20160034號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
31手外科固定復(fù)位鑷國械備20171154號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2022-01-20 變更
32顯微止血夾國械備20170848號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2022-01-20 變更
33顯微剪國械備20170856號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2022-01-20 變更
34外科牽開器國械備20152120號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
35探針國械備20160028號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
36手術(shù)刀國械備20152117號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
37 支撐喉鏡國械備20180222號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany 2022-01-20 變更
38醫(yī)用鑷國械備20152116號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
39骨銼國械備20152119號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
40剝離器國械備20152132號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
41鼻窺器國械備20152118號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
42骨鑿 國械備20152131號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
43刮匙國械備20151685號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
44醫(yī)用剪國械備20151641號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
45止血鉗 國械備20151642號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2022-01-20 變更
46清洗液國械備20220020號(hào)Beckman   Coulter，Inc.Shima   4-28-9 Ibaraki-shi,Osaka 567-0854 Japan2022-01-20 有效
47組織鉗國械備20150692號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2022-01-20 變更
48持針鉗國械備20150693號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2022-01-20 變更
49咬骨鉗國械備20150690號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2022-01-20 變更
50顯微持針鑷國械備20170855號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2022-01-20 變更
51醫(yī)用檢查手套國械備20181687號(hào)ASAP   International Sdn. Bhd. Lot   764, Bidor Industrial Estate 35500 Bidor, Perak Darul Ridzuan Malaysia2022-01-20 變更
52水槍頭國械備20171171號(hào)PRODUITS   DENTAIRES PIERRE ROLLAND SAS17   avenue Gustave Eiffel, Zone Industrielle du Phare, 33700 MERIGNAC FRANCE2022-01-19 變更
53牙科成形片及配套工具國械備20210047號(hào)Dentsply   LLC7290   26th Court East Sarasota, FL 34243 USA2022-01-19 變更
54全自動(dòng)免疫檢驗(yàn)系統(tǒng)用底物液國械備20220019號(hào)Siemens   Healthcare Diagnostics Inc.500   GBC Drive, P.O. Box 6101, Newark, DE 19714, USA2022-01-18 有效
55全自動(dòng)免疫檢驗(yàn)系統(tǒng)用底物液國械備20220018號(hào)Siemens   Healthcare Diagnostics Inc.500   GBC Drive, P.O. Box 6101, Newark, DE 19714, USA2022-01-18 有效
56牙科用刀國械備20220017號(hào)

2022-01-18 有效
57醫(yī)用檢查手套國械備20190201號(hào)Hartalega   NGC Sdn. Bhd.No.1,   Persiaran Tanjung, Kawasan Perindustrian Tanjung,43900 Sepang   Selangor,Malaysia2022-01-17 變更
58醫(yī)用檢查手套國械備20181741號(hào)Hartalega   NGC Sdn. Bhd.  No.1,   Persiaran Tanjung, Kawasan Perindustrian Tanjung,43900 Sepang   Selangor,Malaysia2022-01-17 變更
59醫(yī)用橡膠檢查手套國械備20190237號(hào)HARTALEGA   SDN. BHD.No.7,   Kawasan Perusahaan Suria, Bestari Jaya, 45600 Selangor Darul Ehsan,MALAYSIA2022-01-17 變更
60醫(yī)用檢查手套國械備20190232號(hào)Hartalega   NGC Sdn. Bhd.No.1,   Persiaran Tanjung, Kawasan Perindustrian Tanjung,43900 Sepang   Selangor,Malaysia2022-01-17 變更
61顯微外科手術(shù)器械國械備20200410號(hào)CEATEC   Medizintechnik GmbHUntere   Hauptstr.6 78573 Wurmlingen2022-01-17 變更
62血細(xì)胞分析用溶血?jiǎng)?/span>國械備20220016號(hào)Siemens   Healthcare Diagnostics Inc.Parc   Euromédecine, Rue du Caducée, BP 7290, Montpellier Cedex 4, 34184 France2022-01-17 有效
63血細(xì)胞分析用溶血?jiǎng)?/span>國械備20220015號(hào)Siemens   Healthcare Diagnostics Inc.Parc   Euromédecine, Rue du Caducée, BP 7290, Montpellier Cedex 4, 34184 France2022-01-17 有效
64血細(xì)胞分析用稀釋液國械備20220014號(hào)Siemens   Healthcare Diagnostics Inc.Parc   Euromédecine, Rue du Caducée, BP 7290, Montpellier Cedex 4, 34184 France2022-01-17 有效
65血細(xì)胞分析用溶血?jiǎng)?/span>國械備20220013號(hào)Siemens   Healthcare Diagnostics Inc.Parc   Euromédecine, Rue du Caducée, BP 7290, Montpellier Cedex 4, 34184 France2022-01-17 有效
66一次性使用采樣器國械備20190755號(hào)HELENA   LABORATORIES,CORP.3795   WASHINGTON BLVD. BEAUMONT, TX 77705 2022-01-17 變更
67血細(xì)胞分析用染色液國械備20220012號(hào) シスメックス株式會(huì)社兵庫県小野市匠臺(tái)１７番地2022-01-17 有效
68血細(xì)胞分析用染色液國械備20220011號(hào)シスメックス株式會(huì)社兵庫県小野市匠臺(tái)１７番地2022-01-17 有效
69血細(xì)胞分析用染色液國械備20220010號(hào)シスメックス株式會(huì)社兵庫県小野市匠臺(tái)１７番地2022-01-17 有效
70醫(yī)用固定帶國械備20220009號(hào)Tomato   M&C Co., Ltd.15-11,   Suworam-gil, Seotan-myeon, Pyeongtaek-si, Gyeonggi-do, Korea2022-01-14 有效
71放射治療托架國械備20220008號(hào)Orfit   IndustriesVosveld   9a 2110 Wijnegem Belgium2022-01-14 有效
72放射治療托架國械備20220007號(hào)Orfit   IndustriesVosveld   9a 2110 Wijnegem Belgium2022-01-14 有效
73全自動(dòng)樣品處理系統(tǒng)國械備20181379號(hào)Beckman   Coulter Biomedical GmbHRupert-Mayer-Strasse   44 Muenchen 81379 Germany2022-01-13 變更
74膝關(guān)節(jié)手術(shù)工具國械備20220006號(hào)DePuy   Ireland UC詳情請(qǐng)見附件“生產(chǎn)地址列表”2022-01-13 有效
75免疫顯色試劑國械備20150913號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark2022-01-12 無效
76脊柱外科手術(shù)器械包國械備20161359號(hào)CM   Instrumente GmbH G?ns?cker   56，78532 Tuttlingen，Germany2022-01-12 變更
77手術(shù)照明燈國械備20220005號(hào)Univet   Loupes S.p.a.Via   G. Prati, 87    25086 Rezzato – Brescia   - ITALY2022-01-12 有效
78人工晶狀體輔助植入推進(jìn)器國械備20150879號(hào)株式會(huì)社ニデック愛知縣蒲郡市拾石町前浜34番地142022-01-11 變更
79種植體安裝輔助器械國械備20220004號(hào)Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2022-01-11 有效
80醫(yī)用射線防護(hù)眼鏡國械備20220003號(hào)Phillips   Safety Products123   Lincoln Blvd. Middlesex, NJ US 088462022-01-11 有效
81手術(shù)剪國械備20161654號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
82顯微外科手術(shù)器械包國械備20170928號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
83手術(shù)輔助照明燈國械備20200625號(hào)Gebrüder   Martin GmbH & Co. KG 825   NE 25th Avenue PORTLAND, OR 97232 UNITED STATES2022-01-11 變更
84手術(shù)輔助照明燈國械備20162066號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
85咬骨鉗國械備20160137號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
86基礎(chǔ)外科用剪國械備20151736號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
87外科牽開器國械備20151820號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
88組織鉗國械備20151798號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
89血管鉗國械備20151735號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
90咬骨鉗國械備20151819號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
91Calretinin抗體試劑（免疫組織化學(xué)）國械備20180435號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2022-01-11 變更
92組織鑷國械備20151737號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
93拉鉤國械備20160138號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
94刮匙國械備20160703號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
95結(jié)扎鉗國械備20151618號(hào)Gebrüder   Martin GmbH & Co. KGGebrüder   Martin GmbH & Co. KG2022-01-11 變更
96矯形外科（骨科）手術(shù)器械包國械備20171178號(hào)Gebrüder   Martin GmbH & Co. KGKLS   Martin Platz 1, 78532 Tuttlingen, Germany2022-01-11 變更
97種植體安裝輔助工具國械備20190673號(hào)

2022-01-10 變更
98緩沖液國械備20180454號(hào)Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2022-01-10 變更
99樣本稀釋液國械備20190210號(hào)Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2022-01-10 變更
100免疫顯色試劑國械備20181470號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2022-01-07 無效
101醫(yī)用放大鏡國械備20220002號(hào)Univet   Loupes S.p.a.via   Giovanni prati,87 25086 Rezzato (BS)-Italy2022-01-06 有效
102生物顯微鏡國械備20210287號(hào)オリンパス株式會(huì)社長野県上伊那郡辰野町大字伊那富6666番地2022-01-06 變更
103膀胱癌細(xì)胞染色體及基因異常檢測(cè)試劑盒（原位雜交法）國械備20181111號(hào)Abbott   Molecular Inc.1300   East Touhy Avenue, Des Plaines, IL 60018, USA2022-01-05 變更
104Glypican   3抗體試劑（免疫組織化學(xué)）國械備20180596號(hào)Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2022-01-05 變更
105Helicobacter   phlori抗體試劑（免疫組織化學(xué)）國械備20180439號(hào)Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2022-01-05 變更
106MOC-31抗體試劑（免疫組織化學(xué)）國械備20180642號(hào)Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2022-01-05 變更
107細(xì)胞周期蛋白D1抗體試劑（免疫組織化學(xué)）國械備20190054號(hào)Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2022-01-05 變更
108bcl-2抗體試劑（免疫組織化學(xué)）國械備20190040號(hào)Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2022-01-05 變更
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110CD79a抗體試劑（免疫組織化學(xué)） 國械備20190055號(hào)Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2022-01-05 變更
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112牙科拋光條國械備20181566號(hào)

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113全自動(dòng)血沉分析儀國械備20220001號(hào)ALIFAX   S.r.l.Via   Merano 30, 33045 Nimis(UD), ITALY2022-01-04 有效
114緩沖液國械備20190070號(hào)Helena   Biosciences EuropeQueensway   South, Team Valley Trading Estate, Gateshead, Tyne and Wear, NE11 0SD, United   Kingdom2022-01-04 變更
115造口袋國械備20200641號(hào)Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2022-01-04 變更
116造口袋國械備20190931號(hào)Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary2022-01-04 變更

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