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國(guó)家局2023年12月批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案123項(xiàng)
發(fā)布日期:2024-01-11 16:16瀏覽次數(shù):1327次
來(lái)自國(guó)家藥監(jiān)局消息，2023年12月，國(guó)家藥監(jiān)局累計(jì)批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案123項(xiàng)，包括：肌電導(dǎo)聯(lián)線、醫(yī)用離心機(jī)、手術(shù)輔助照明燈、喉鏡、峨眉鑿、耳鏡、防褥瘡墊、種植體安裝輔助器械等進(jìn)口第一類醫(yī)療器械備案產(chǎn)品，一起看正文。

來(lái)自國(guó)家藥監(jiān)局消息，2023年12月，國(guó)家藥監(jiān)局累計(jì)批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案123項(xiàng)，包括：肌電導(dǎo)聯(lián)線、醫(yī)用離心機(jī)、手術(shù)輔助照明燈、喉鏡、峨眉鑿、耳鏡、防褥瘡墊、種植體安裝輔助器械等進(jìn)口第一類醫(yī)療器械備案產(chǎn)品，一起看正文。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2023年12月批準(zhǔn)進(jìn)口第一類醫(yī)療器械備案產(chǎn)品列表

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肌電導(dǎo)聯(lián)線國(guó)械備20210504號(hào)Natus   Manufacturing LimitedIDA   Business Park Gort Co.Galway Ireland2023-12-29 變更
2腦電/肌電導(dǎo)聯(lián)線國(guó)械備20210518號(hào)Natus   Neurology Incorporated3150   Pleasant View Road Middleton, Wisconsin 53562 USA;IDA Business Park Gort   Co.Galway Ireland.2023-12-29 變更
3醫(yī)用離心機(jī)國(guó)械備20230604號(hào)Jointechlabs,   Inc421   Lithia Pinecrest Road Brandon, FL 33511 United States of America2023-12-28 有效
4手術(shù)輔助照明燈國(guó)械備20150129  號(hào)XENOSYS   CO., LTD.2F,   2, Venture-ro 100beon-gil, Yeonsu-gu, Incheon2023-12-28 變更
5組合式骨牽引架國(guó)械備20220193號(hào)ADSM   SAS7b   RUE LAVOISIER 69680 CHASSIEU France2023-12-28 變更
6熱塑膜國(guó)械備20230603號(hào)Orfit   Industries Vosveld 9A 2110 Wijnegem Belgium2023-12-28 有效
7喉鏡國(guó)械備20230602號(hào)HEINE   Optotechnik GmbH & Co. KGDornierstr.   6, 82205 Gilching, Germany2023-12-28 有效
8CD58檢測(cè)試劑（流式細(xì)胞儀法-PE)國(guó)械備20230601號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-12-27 有效
9口腔科器械國(guó)械備20230600號(hào)FORGEMAN   INSTRUMENTS CO.Near   Masjid Jamal-E-Mustafa, Nasir Road, Sialkot - Pakistan2023-12-27 有效
10峨眉鑿國(guó)械備20151880號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg Germany2023-12-27 變更
11骨刮匙國(guó)械備20152020號(hào)Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-12-27 變更
12骨科手術(shù)器械通用手柄國(guó)械備20230599號(hào)Zimmer   Inc.1800   W. Center Street, Warsaw, Indiana, 46580, USA2023-12-27 有效
13聚酯襯墊國(guó)械備20210401號(hào)Optomed   OyjYrttipellontie   1 FI-90230 Oulu Finland2023-12-27 無(wú)效
14鈦合金椎籠系統(tǒng)手術(shù)器械（包）國(guó)械備20180575號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-12-27 變更
15頸椎系列手術(shù)器械（包）國(guó)械備20180568號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-12-26 變更
16脊椎固定手術(shù)用器械（包）國(guó)械備20180556號(hào)亞太醫(yī)療器材科技股份有限公司彰化縣伸港鄉(xiāng)溪底村工三路二號(hào)2023-12-26 變更
17引流袋國(guó)械備20170603號(hào)Serres   OyKeskustie   23, 61850 Kauhajoki As Finland2023-12-26 變更
18耳鏡國(guó)械備20230598號(hào)HEINE   Optotechnik GmbH & Co. KGDornierstr.   6 82205 Gilching Germany2023-12-25 有效
19壓力繃帶國(guó)械備20230597號(hào)SIGVARIS   AGGr?blistrasse   8，CH-9014 St. Gallen，Switzerland2023-12-25 有效
20壓力繃帶國(guó)械備20181626號(hào)上蕎股份有限公司彰化縣社頭鄉(xiāng)廣興村中興路47號(hào)2023-12-25 變更
21樣本稀釋液國(guó)械備20210596號(hào)富士レビオ株式會(huì)社日本國(guó)東京都八王子市小宮町51番地2023-12-22 變更
22全自動(dòng)免疫檢驗(yàn)系統(tǒng)用底物液國(guó)械備20160413號(hào)富士レビオ株式會(huì)社東京都八王子市小宮町５１番地2023-12-22 變更
23研磨材料國(guó)械備20160322號(hào)Hopf,   Ringleb & Co.GmbH &Cie.Gardeschützenweg   82, 12203 Berlin, Germany2023-12-22 變更
24醫(yī)用透氣膠布國(guó)械備20230596號(hào)仙峰科技實(shí)業(yè)有限公司臺(tái)中市后里區(qū)義里里甲后路一段352巷65號(hào)2023-12-21 有效
25防褥瘡墊國(guó)械備20180526號(hào)ROHO,   INC.100   North Florida Avenue, Belleville, Illinois, 62221, US2023-12-21 變更
26唇頰牽開(kāi)器國(guó)械備20230357號(hào)Align   Technology, Inc.Aligntech   de Mexico S. de R.L. de C.V.  Boulevard   Independencia 1951, Parque Industrial    Salvacar, Cd. Juarez Chihuahua, MEXICO 325752023-12-21 變更
27髖關(guān)節(jié)手術(shù)工具國(guó)械備20210138號(hào)Symmetry   Medical Manufacturing, Inc.486   West 350 North, Warsaw, Indiana 46582 USA2023-12-21 變更
28無(wú)源手術(shù)器械國(guó)械備20230595號(hào)Ulrich   AGM?venstra?e   12, 9015 St. Gallen,  SCHWEIZ2023-12-21 有效
29MLH1抗體試劑（免疫組織化學(xué)）國(guó)械備20210583號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-21 變更
30MSH6抗體試劑（免疫組織化學(xué)）國(guó)械備20210599號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-12-21 變更
31PMS2抗體試劑（免疫組織化學(xué)）國(guó)械備20210586號(hào) Leica Biosystems Newcastle Ltd Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-12-21 變更
32MSH2抗體試劑（免疫組織化學(xué)）國(guó)械備20210584號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-21 變更
33髖關(guān)節(jié)手術(shù)工具國(guó)械備20190989號(hào)Howmedica   Osteonics Corp見(jiàn)附件2023-12-21 變更
34喉鏡國(guó)械備20210089號(hào)SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
35基礎(chǔ)外科手術(shù)器械國(guó)械備20210083號(hào)SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
36口腔科手術(shù)器械國(guó)械備20210081號(hào)SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
37耳鼻喉科手術(shù)器械國(guó)械備20210093號(hào)SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
38耳鏡國(guó)械備20210088號(hào)SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
39骨科手術(shù)器械國(guó)械備20210092號(hào)SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
40婦產(chǎn)科手術(shù)器械國(guó)械備20210082號(hào)SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
41種植體安裝輔助器械國(guó)械備20180987號(hào)ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-12-19 變更
42Serotonin抗體試劑（免疫組織化學(xué)）   BOND Ready-to-Use Primary Antibody
   
    Serotonin (Polyclonal)		國(guó)械備20190091號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-12-19 無(wú)效
43Thyroid   Stimulating Hormone抗體試劑（免疫組織化學(xué)）國(guó)械備20190632號(hào)Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-12-19 無(wú)效
44ZAP-70抗體試劑（免疫組織化學(xué)）國(guó)械備20190813號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-19 無(wú)效
45CD33抗體試劑（免疫組織化學(xué)法）國(guó)械備20230594號(hào) Leica Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-12-19 有效
46切片機(jī)國(guó)械備20180641號(hào)大和光機(jī)工業(yè)株式會(huì)社埼玉県朝霞市膝折町二丁目14番43號(hào)2023-12-19 無(wú)效
47牙用探針國(guó)械備20151312號(hào)Cortex   Dental Implants Industries Ltd.
2023-12-19 變更
48螺絲起國(guó)械備20140226號(hào)/
2023-12-19 變更
49口腔手術(shù)器械國(guó)械備20181405號(hào)Cortex   Dental Implants Industries Ltd.Shlomi   Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel2023-12-19 變更
50牙科塑料基底國(guó)械備20200406號(hào) Cortex Dental Implants Industries Ltd.Shlomi   Industrial Zone, Ya' ara Street 26, P.O.Box 125, 2283202, Israel2023-12-19 變更
51扭力扳手 國(guó)械備20140227 號(hào)Cortex   Dental Implants Industries LTDShlomi   Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel2023-12-19 變更
52牙科種植體手術(shù)工具包國(guó)械備20161141號(hào)Cortex   Dental Implants Industries LTDShlomi   Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel2023-12-19 變更
53種植體手術(shù)工具國(guó)械備20151307號(hào)/
2023-12-19 變更
54牙科種植定位器國(guó)械備20151313號(hào)Cortex   Dental Implants Industries Ltd.
2023-12-19 變更
55種植體掃描體國(guó)械備20171019號(hào)Cortex   Dental Implants Industries Ltd.Shlomi   Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel2023-12-19 變更
56扭力扳手國(guó)械備20160092號(hào)Nobel   Biocare AB22715   Savi Ranch Parkway Yorba Linda California 92887 USA；Dimbov?gen 2 SE-691 51   Karlskoga Sweden；Engvej 33, 3330 G?rl?se, Denmark2023-12-19 變更
57超聲波清洗機(jī)國(guó)械備20230593號(hào)STEELCO   SPA31039   RIESE PIO X (TV) –VIA BALEGANTE 27 (ITA) –Italy2023-12-19 有效
58助行器國(guó)械備20210323號(hào)James   Leckey Design LtdBallinderry   Road, Lisburn, Antrim BT28 2SA United Kingdom2023-12-18 變更
59醫(yī)用放大鏡國(guó)械備20230592號(hào)I.C.LERCHER-Selation   GmbHIm   Sagenloh 8 78333 Stockach2023-12-18 有效
60眼用刮匙國(guó)械備20230591號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-18 有效
61顯微刀國(guó)械備20161096號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France 2023-12-15 變更
62顯微針國(guó)械備20160808號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
63基礎(chǔ)外科手術(shù)器械包國(guó)械備20162039號(hào)Integra   MicroFrance SAS/2023-12-15 變更
64顯微鑷國(guó)械備20161698號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Badstra?e 8, 78532 Tuttlingen,   GERMANY2023-12-15 變更
65支撐喉鏡國(guó)械備20160933號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
66耳鉗國(guó)械備20161931號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE 2023-12-15 變更
67鼻中隔咬骨鉗國(guó)械備20161934號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Bischof-Sproll-Stra?e 2, 78532   Tuttlingen, Germany; 31 Rue Malaingre, 52800 Nogent, France; Lehrstrasse 11,   78589 Dürbheim, DEUTSCHLAND; G?ns?cker 15, 78532 Tuttlingen, DEUTSCHLAND  2023-12-15 變更
68拉鉤國(guó)械備20160889號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Bischof-Sproll-Stra?e 2, 78532   Tuttlingen, Germany; Badstra?e 8, 78532 Tuttlingen, GERMANY2023-12-15 變更
69耳用骨鑿國(guó)械備20162029號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
70五官科吸引管國(guó)械備20161283號(hào)Integra   MicroFrance SAS  Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Rue du Grand-Pré 10, 1007   Lausanne, Switzerland2023-12-15 變更
71探針國(guó)械備20160623號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France2023-12-15 變更
72鼻腔撐開(kāi)器國(guó)械備20162036號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Bischof-Sproll-Stra?e 2, 78532   Tuttlingen, Germany; G?ns?cker 15, 78532 Tuttlingen, DEUTSCHLAND; Gotenstra?e   5, 78532 Tuttlingen, Deutschland 2023-12-15 變更
73顯微剪國(guó)械備20160807號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
74顯微鉤國(guó)械備20160596號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
75手術(shù)剪國(guó)械備20161968號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE；31 Rue Malaingre, 52800 Nogent,   France；Weilheimerstrasse 20, Wurmlingen Baden-Wurttemberg, GERMANY 785732023-12-15 變更
76乳突牽開(kāi)器國(guó)械備20160597號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Am Eichbühl 70-72, 78532   Tuttlingen, Deutschland; Lehrstrasse 11, 78589 Dürbheim, GERMANY2023-12-15 變更
77耳科手術(shù)壓平器國(guó)械備20171215號(hào)Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
78鼻骨鑿國(guó)械備20161967號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
79顯微喉鉗國(guó)械備20161095號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE;31 Rue Malaingre, 52800 Nogent,   France2023-12-15 變更
80顯微剝離器國(guó)械備20161282號(hào)Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France; Badstra?e 8, 78532 Tuttlingen, GERMANY2023-12-15 變更
81脊柱外科手術(shù)器械包國(guó)械備20151700號(hào)Synthes   GmbH1051   Synthes Avenue, Monument, CO 80132, USA; 35 Airport
   
    Road, Horseheads, NY 14845, USA; 1303 Goshen Parkway,
   
    West Chester, PA 19380, USA; ImBifang 6,4614 H?gendorf,
   
    Switzerland ; Via Cavazz 5, 6805 Mezzovico, Switzerland;
   
    Muracherstrasse 3,2544 Bettlach, Switzerland;
   
    Dornacherstrasse 20, 4710 Balsthal, Switzerland;
   
    Kanalstrasse West 30, 3942 Raron, Switzerland;
   
    Solothurnstrasse 186, 2540 Grenchen, Switzerland;
   
    ImKirchenhürstle 4-6, 79224 Umkirchb.Freiburg, Germany;
   
    Karolingerstrasse 16, 5020 Salzburg, Austria;
   
    Eimattstrasse 3,4436 Oberdorf, Switzerland;
   
    Bohnackerweg 5, 2545 Selzach, Switzerland
   
   		2023-12-15 變更
82種植體輔助安裝套裝國(guó)械備20200268號(hào)//2023-12-15 無(wú)效
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95醫(yī)用頭燈國(guó)械備20230585號(hào)(?)??????????   ?? ???? 592023-12-11 有效
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108脊柱外科手術(shù)器械包國(guó)械備20180006號(hào)寶楠生技股份有限公司臺(tái)北市內(nèi)湖區(qū)瑞光路258巷50號(hào)3樓2023-12-06 變更
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112HPV探針試劑（原位雜交法） 國(guó)械備20230573號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-04 有效
113HPV探針試劑（原位雜交法）國(guó)械備20230572號(hào)Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-04 有效
114組織切片機(jī)國(guó)械備20230571號(hào)Milestone   s.r.l.CL   LLEIDA, 17-23. 43712 - LLOREN? DEL PENEDES    (TARRAGONA)2023-12-01 有效
115眼用鉗國(guó)械備20230570號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-01 有效
116眼用鉗國(guó)械備20230569號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-01 有效
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118眼科用鏟國(guó)械備20230567號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-01 有效
119眼用刮匙國(guó)械備20230565號(hào)KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-01 有效
120眼用鉤國(guó)械備20220547號(hào)KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-12-01 變更
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