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國家局2023年12月批準進口第一類醫療器械產品備案123項
發布日期:2024-01-11 16:16瀏覽次數:1087次
來自國家藥監局消息，2023年12月，國家藥監局累計批準進口第一類醫療器械產品備案123項，包括：肌電導聯線、醫用離心機、手術輔助照明燈、喉鏡、峨眉鑿、耳鏡、防褥瘡墊、種植體安裝輔助器械等進口第一類醫療器械備案產品，一起看正文。

來自國家藥監局消息，2023年12月，國家藥監局累計批準進口第一類醫療器械產品備案123項，包括：肌電導聯線、醫用離心機、手術輔助照明燈、喉鏡、峨眉鑿、耳鏡、防褥瘡墊、種植體安裝輔助器械等進口第一類醫療器械備案產品，一起看正文。

進口第一類醫療器械產品備案.jpg

2023年12月批準進口第一類醫療器械備案產品列表

序號產品名稱備案號備案人名稱原文生產地址原文備案日期狀態
1肌電導聯線國械備20210504號Natus   Manufacturing LimitedIDA   Business Park Gort Co.Galway Ireland2023-12-29 變更
2腦電/肌電導聯線國械備20210518號Natus   Neurology Incorporated3150   Pleasant View Road Middleton, Wisconsin 53562 USA;IDA Business Park Gort   Co.Galway Ireland.2023-12-29 變更
3醫用離心機國械備20230604號Jointechlabs,   Inc421   Lithia Pinecrest Road Brandon, FL 33511 United States of America2023-12-28 有效
4手術輔助照明燈國械備20150129  號XENOSYS   CO., LTD.2F,   2, Venture-ro 100beon-gil, Yeonsu-gu, Incheon2023-12-28 變更
5組合式骨牽引架國械備20220193號ADSM   SAS7b   RUE LAVOISIER 69680 CHASSIEU France2023-12-28 變更
6熱塑膜國械備20230603號Orfit   Industries Vosveld 9A 2110 Wijnegem Belgium2023-12-28 有效
7喉鏡國械備20230602號HEINE   Optotechnik GmbH & Co. KGDornierstr.   6, 82205 Gilching, Germany2023-12-28 有效
8CD58檢測試劑（流式細胞儀法-PE)國械備20230601號BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212023-12-27 有效
9口腔科器械國械備20230600號FORGEMAN   INSTRUMENTS CO.Near   Masjid Jamal-E-Mustafa, Nasir Road, Sialkot - Pakistan2023-12-27 有效
10峨眉鑿國械備20151880號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg Germany2023-12-27 變更
11骨刮匙國械備20152020號Waldemar   Link GmbH & Co.KGBarkhausenweg   10 22339 Hamburg GERMANY2023-12-27 變更
12骨科手術器械通用手柄國械備20230599號Zimmer   Inc.1800   W. Center Street, Warsaw, Indiana, 46580, USA2023-12-27 有效
13聚酯襯墊國械備20210401號Optomed   OyjYrttipellontie   1 FI-90230 Oulu Finland2023-12-27 無效
14鈦合金椎籠系統手術器械（包）國械備20180575號亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-12-27 變更
15頸椎系列手術器械（包）國械備20180568號亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-12-26 變更
16脊椎固定手術用器械（包）國械備20180556號亞太醫療器材科技股份有限公司彰化縣伸港鄉溪底村工三路二號2023-12-26 變更
17引流袋國械備20170603號Serres   OyKeskustie   23, 61850 Kauhajoki As Finland2023-12-26 變更
18耳鏡國械備20230598號HEINE   Optotechnik GmbH & Co. KGDornierstr.   6 82205 Gilching Germany2023-12-25 有效
19壓力繃帶國械備20230597號SIGVARIS   AGGr?blistrasse   8，CH-9014 St. Gallen，Switzerland2023-12-25 有效
20壓力繃帶國械備20181626號上蕎股份有限公司彰化縣社頭鄉廣興村中興路47號2023-12-25 變更
21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2023-12-22 變更
22全自動免疫檢驗系統用底物液國械備20160413號富士レビオ株式會社東京都八王子市小宮町５１番地2023-12-22 變更
23研磨材料國械備20160322號Hopf,   Ringleb & Co.GmbH &Cie.Gardeschützenweg   82, 12203 Berlin, Germany2023-12-22 變更
24醫用透氣膠布國械備20230596號仙峰科技實業有限公司臺中市后里區義里里甲后路一段352巷65號2023-12-21 有效
25防褥瘡墊國械備20180526號ROHO,   INC.100   North Florida Avenue, Belleville, Illinois, 62221, US2023-12-21 變更
26唇頰牽開器國械備20230357號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髖關節手術工具國械備20210138號Symmetry   Medical Manufacturing, Inc.486   West 350 North, Warsaw, Indiana 46582 USA2023-12-21 變更
28無源手術器械國械備20230595號Ulrich   AGM?venstra?e   12, 9015 St. Gallen,  SCHWEIZ2023-12-21 有效
29MLH1抗體試劑（免疫組織化學）國械備20210583號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）國械備20210599號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）國械備20210586號 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）國械備20210584號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-21 變更
33髖關節手術工具國械備20190989號Howmedica   Osteonics Corp見附件2023-12-21 變更
34喉鏡國械備20210089號SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
35基礎外科手術器械國械備20210083號SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
36口腔科手術器械國械備20210081號SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
37耳鼻喉科手術器械國械備20210093號SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
38耳鏡國械備20210088號SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
39骨科手術器械國械備20210092號SHENZHEN   CHENLI MEDICAL INSTRUMENTSChohan   Street, Mian Shakeel Road, Model Town,Sialkot-Pakistan2023-12-21 變更
40婦產科手術器械國械備20210082號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械備20180987號ALTATEC   GmbHMaybachstr.   5, 71299 Wimsheim, Germany2023-12-19 變更
42Serotonin抗體試劑（免疫組織化學）   BOND Ready-to-Use Primary Antibody
   
    Serotonin (Polyclonal)		國械備20190091號Leica   Biosystems Newcastle LtdBalliol   Business Park West Benton Lane Newcastle upon Tyne NE12 8EW United Kingdom2023-12-19 無效
43Thyroid   Stimulating Hormone抗體試劑（免疫組織化學）國械備20190632號Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2023-12-19 無效
44ZAP-70抗體試劑（免疫組織化學）國械備20190813號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-19 無效
45CD33抗體試劑（免疫組織化學法）國械備20230594號 Leica Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom 2023-12-19 有效
46切片機國械備20180641號大和光機工業株式會社埼玉県朝霞市膝折町二丁目14番43號2023-12-19 無效
47牙用探針國械備20151312號Cortex   Dental Implants Industries Ltd.
2023-12-19 變更
48螺絲起國械備20140226號/
2023-12-19 變更
49口腔手術器械國械備20181405號Cortex   Dental Implants Industries Ltd.Shlomi   Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel2023-12-19 變更
50牙科塑料基底國械備20200406號 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 國械備20140227 號Cortex   Dental Implants Industries LTDShlomi   Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel2023-12-19 變更
52牙科種植體手術工具包國械備20161141號Cortex   Dental Implants Industries LTDShlomi   Industrial Zone Ya’ara street 26.P.O.BOX 125,22832, Israel2023-12-19 變更
53種植體手術工具國械備20151307號/
2023-12-19 變更
54牙科種植定位器國械備20151313號Cortex   Dental Implants Industries Ltd.
2023-12-19 變更
55種植體掃描體國械備20171019號Cortex   Dental Implants Industries Ltd.Shlomi   Industrial Zone, Ya’ara Street26, P.O.Box125,2283202,Israel2023-12-19 變更
56扭力扳手國械備20160092號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超聲波清洗機國械備20230593號STEELCO   SPA31039   RIESE PIO X (TV) –VIA BALEGANTE 27 (ITA) –Italy2023-12-19 有效
58助行器國械備20210323號James   Leckey Design LtdBallinderry   Road, Lisburn, Antrim BT28 2SA United Kingdom2023-12-18 變更
59醫用放大鏡國械備20230592號I.C.LERCHER-Selation   GmbHIm   Sagenloh 8 78333 Stockach2023-12-18 有效
60眼用刮匙國械備20230591號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-18 有效
61顯微刀國械備20161096號Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France 2023-12-15 變更
62顯微針國械備20160808號Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
63基礎外科手術器械包國械備20162039號Integra   MicroFrance SAS/2023-12-15 變更
64顯微鑷國械備20161698號Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Badstra?e 8, 78532 Tuttlingen,   GERMANY2023-12-15 變更
65支撐喉鏡國械備20160933號Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
66耳鉗國械備20161931號Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE 2023-12-15 變更
67鼻中隔咬骨鉗國械備20161934號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拉鉤國械備20160889號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耳用骨鑿國械備20162029號Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
70五官科吸引管國械備20161283號Integra   MicroFrance SAS  Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; Rue du Grand-Pré 10, 1007   Lausanne, Switzerland2023-12-15 變更
71探針國械備20160623號Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE; 31 Rue Malaingre, 52800   Nogent, France2023-12-15 變更
72鼻腔撐開器國械備20162036號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顯微剪國械備20160807號Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
74顯微鉤國械備20160596號Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
75手術剪國械備20161968號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乳突牽開器國械備20160597號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耳科手術壓平器國械備20171215號Integra   MicroFrance SASLe   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
78鼻骨鑿國械備20161967號Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE2023-12-15 變更
79顯微喉鉗國械備20161095號Integra   MicroFrance SAS Le   Pavillon, 03160 SAINT AUBIN LE MONIAL, FRANCE;31 Rue Malaingre, 52800 Nogent,   France2023-12-15 變更
80顯微剝離器國械備20161282號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脊柱外科手術器械包國械備20151700號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械備20200268號//2023-12-15 無效
83清洗液國械備20220544號DiaSorin   Italia S.p.A.Von   Hevesy-Str. 3, 63128 Dietzenbach, Germany2023-12-15 變更
84增強液國械備20200322號DiaSorin   Italia S.p.A.Von-Hevesy-Str.   3, 63128 Dietzenbach, Germany2023-12-15 變更
85清洗液國械備20151113號Roche   Diagnostics GmbHSandhofer   Strasse 116， 68305 Mannheim，Germany2023-12-14 變更
86眼用擴張器國械備20230590號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-14 有效
87眼用注入器國械備20230589號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-14 有效
88開瞼器國械備20230588號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-14 有效
89彈性繃帶國械備20230587號LUROPAS   del Dott. Molinari & C. S.r.l.Via   Antonio Vivaldi, 4 - 24040 Calvenzano (BG) - Italy2023-12-13 有效
90超聲潔牙機工作尖國械備20191244號//2023-12-13 變更
91組織脫水機國械備20230586號Milestone   S.r.l.Via   Fatebenefratelli, 1/5 24010 SORISOLE (BG) Corso Europa Unita, 6 IT – 24030   VALBREMBO (BG) 2023-12-12 有效
92耳鏡國械備20190465號Tyto   Care Ltd.12   Haomanut Street Netanya,4250445,Israel2023-12-12 變更
93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2023-12-12 變更
94清洗液國械備20151528號富士レビオ株式會社1.   東京都八王子市小宮町５１番地; 2. 福井県敦賀市東洋町10番地24號2023-12-11 變更
95醫用頭燈國械備20230585號(?)??????????   ?? ???? 592023-12-11 有效
96膝關節手術工具國械備20230584號Zimmer   CAS75   Queen Street, Suite 3300, Montreal, Quebec, H3C 2N6, Canada2023-12-08 有效
97眼用沖吸器及手柄國械備20220537號KATENA   PRODUCTS, INC.6   CAMPUS DRIVE, SUITE 310, Parsippany, NJ 070542023-12-08 變更
98開瞼器國械備20230583號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
99眼用固位器國械備20230582號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
100眼用固位器國械備20230581號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
101眼科用測量器國械備20230579號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
102標記環國械備20230578號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-08 有效
103肩關節手術工具國械備20230576號DePuy   Ireland UC見附件2023-12-07 有效
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105脊柱手術器械包國械備20191117號Synthes   GmbH見附件2023-12-07 變更
106人體定位墊國械備20230575號 Orfit IndustriesVosveld   9A 2110 Wijnegem Belgium2023-12-07 有效
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108脊柱外科手術器械包國械備20180006號寶楠生技股份有限公司臺北市內湖區瑞光路258巷50號3樓2023-12-06 變更
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110樣本稀釋液國械備20140356號Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, Massachusetts 02032, USA2023-12-04 無效
111樣本釋放劑國械備20151865號Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, Massachusetts 02032, USA2023-12-04 無效
112HPV探針試劑（原位雜交法） 國械備20230573號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）國械備20230572號Leica   Biosystems Newcastle LtdBalliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom2023-12-04 有效
114組織切片機國械備20230571號Milestone   s.r.l.CL   LLEIDA, 17-23. 43712 - LLOREN? DEL PENEDES    (TARRAGONA)2023-12-01 有效
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116眼用鉗國械備20230569號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-01 有效
117眼用鉤國械備20230568號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-01 有效
118眼科用鏟國械備20230567號KATENA   PRODUCTS, INC.4   Middlebury Boulevard Unit #1 Randolph, NJ USA 078692023-12-01 有效
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