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2025年12月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2026-01-15 00:00瀏覽次數(shù):197次
來自國家藥監(jiān)局近日披露的數(shù)據(jù),2025年12月國家藥監(jiān)局累計(jì)批準(zhǔn)牙膠充填器、種植輔助材料、凝血分析用稀釋液、運(yùn)送培養(yǎng)基、彈性醫(yī)用膠布、顯微持針鑷、口腔科器械、研光器、神經(jīng)和心血管手術(shù)器械、基礎(chǔ)外科手術(shù)器械等129個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng),一起來看具體內(nèi)容。

來自國家藥監(jiān)局近日披露的數(shù)據(jù),2025年12月國家藥監(jiān)局累計(jì)批準(zhǔn)牙膠充填器、種植輔助材料、凝血分析用稀釋液、運(yùn)送培養(yǎng)基、彈性醫(yī)用膠布、顯微持針鑷、口腔科器械、研光器、神經(jīng)和心血管手術(shù)器械、基礎(chǔ)外科手術(shù)器械等129個(gè)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案事項(xiàng),一起來看具體內(nèi)容。

進(jìn)口第一類醫(yī)療器械產(chǎn)品備案.jpg

2025年12月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息

序號醫(yī)療器械產(chǎn)品名稱醫(yī)療器械備案號備案人名稱原文生產(chǎn)地址原文
1橡皮障國械備20220240號Dent4You   AGLot   6, Lorong Bemban 2,Bemban Industrial Park, Batu Gajah Perak,31000, Malaysia;   1245 Home Avenue, Akron, Ohio, 44301, United States
2骨水泥槍國械備20220545號Tecres   S.p.A.Via   Andrea Doria, 6 Sommacampagna (VR) 37066 Italy
3手術(shù)用頭架國械備20150066號Integra   LifeSciences Corporation4900   Charlemar Dr. Building A, Cincinnati, OH 45227 USA
4顱骨鉆國械備20240155號Brainlab   SEOlof-Palme-Stra?e   9, 81829 München,Germany
5導(dǎo)航手術(shù)工具國械備20200654號Brainlab   SEOlof-Palme-Stra?e   9, 81829 München,Germany
6增強(qiáng)液國械備20200322號DiaSorin   Italia S.p.A.Von-Hevesy-Str.   3, 63128 Dietzenbach, Germany
7胸腔組織鉗國械備20151160號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
8二尖瓣膜拉鉤國械備20151161號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
9胸腔止血鉗國械備20151162號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
10基礎(chǔ)外科手術(shù)器械國械備20151337號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
11咬骨鉗國械備20151165號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
12心臟手術(shù)剪國械備20151164號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
13肋骨合攏器國械備20151152號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
14二尖瓣膜拉鉤國械備20151153號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
15胸腔鑷國械備20151159號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
16骨用牽開器國械備20151146號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
17頸椎牽開器國械備20151148號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
18腹部手術(shù)牽開器國械備20151151號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
19骨科撐開器國械備20151144號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
20倒置生物顯微鏡國械備20250071號NIKON   CORPORATION471,   NAGAODAI-CHO, SAKAE-KU, YOKOHAMA, KANAGAWA, 244-8533, JAPAN
21倒置生物顯微鏡國械備20230515號株式會社二コン471,   Nagaodai-Cho, Sakae-Ku, Yokohama, Kanagawa, 244-8533, Japan
22生物顯微鏡國械備20240266號NIKON   CORPORATION471,   NAGAODAI-CHO, SAKAE-KU, YOKOHAMA, KANAGAWA, 244-8533, JAPAN
23生物顯微鏡國械備20220063號株式會社二コン244-8533 日本神奈川県橫浜市栄區(qū)長尾臺町471
24口腔觀察儀國械備20250476號Dentall   Co., Ltd.301-905,   Bucheon Technopark, 345, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14501,   Republic of Korea
25全自動(dòng)核酸提取純化儀國械備20181731號Tecan   Schweiz AGSeestraβe   103, 8708 M?nnedorf, Switzerland
26全自動(dòng)核酸提取純化儀國械備20160221號Tecan   Schweiz AGSeestraβe   103, CH-8708 Mannedorf, Switzerland
27雙目放大鏡國械備20250475號ExamVision   A/SIndustrivej   11, 8305 Samsφ, Denmark
28正畸鉗國械備20170044號WORLD   BIO TECH CO., LTD.BizCenter-302,(Sangdaewon-dong,   SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do
29打磨拋光組件國械備20170041號WORLD   BIO TECH CO., LTD.BizCenter-302,(Sangdaewon-dong,   SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do
30義齒修復(fù)工具國械備20161964號Zest   Anchors, LLC2230   Enterprise Street, Escondido, California, 92029, USA
31骨科外固定夾板國械備20181768號THUASNE118/120,   rue Marius Aufan BP 243 FR-92307 LEVALLOIS-PERRET
32基礎(chǔ)外科手術(shù)器械國械備20250474號EKAL   SURGICAL WORKSKashmir   Road, Ismailabad, Pacca Garha, Sialkot - 51310 - Pakistan
33口腔治療器具國械備20250473號EKAL   SURGICAL WORKSKashmir   Road, Ismailabad, Pacca Garha, Sialkot - 51310 - Pakistan
34口腔治療器具國械備20250472號BILLU   BROTHERS SURGICAL CO.JEEWAN   PURA, SIALKOT-51310, PAKISTAN
35口腔治療器具國械備20250471號SOBYTEK   (PRIVATE) LIMITEDRoras   Road, Muzaffar Pur, Sialkot 51310 – Pakistan
36基礎(chǔ)外科手術(shù)器械國械備20250470號J.R.   BROTHERS SURGICAL INSTRUMENTS Incorporating the NOMI INDUSTRIES BrandP.O.   Box 1195 Near Peer Hara, Harrar, Sialkot Pakistan
37牙科角度尺國械備20250469號Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, LIECHTENSTEIN;Bremschlstrasse 16, 6706 Bürs, AUSTRIA
38Kappa鏈抗體試劑(免疫組織化學(xué))國械備20180643號Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA
39過碘酸雪夫染色液(糖原染色液,PAS) 國械備20250170號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA
40顯微外科手術(shù)器械國械備20151338號Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
41去血片洗板機(jī)國械備20200542號Wallac   Oy7   rue de Madrid , 67300 SCHILTIGHEIM, FRANCE
42一次性使用唾液采集器國械備20230045號DNA   Genotek Inc.3000   - 500 Palladium Drive; Ottawa, ON; K2V1C2 CANADA
43牙科種植體通用取出工具包國械備20250468號Neobiotech   Co., Ltd.70,   Sinpyeong-ro, Jijeong-myeon, Wonju-si, Gangwon-do, Republic of Korea
44牙科拋光磨頭國械備20250467號EVE   Ernst Vetter GmbHNeureutstra?e   6 75210 Keltern Germany
45樣本稀釋液國械備20200454號The   Binding Site Group Ltd8   Calthorpe Road Edgbaston Birmingham B15 1QT United Kingdom
46檢查手套國械備20170721號Medline   Industries, LPPTD   3274 BATU 4 1/2 JALAN BAKRI MURA, Johor MALAYSIA 84000
   
   
   
    LOT 1, JALAN 3, KAWASAN PERUSAHAAN BANDER BARU SALAK TINGGI, SEPANG,   Selangor MALAYSIA 43900
   
   
   
    PLOT4, KAW. PERINDUSTRIANTANJUNG KLING, TANJUNG BRUAS JETIMELAKA, Melaka   MALAYSIA 76400
   
   
47檢查手套國械備20170722號Medline   Industries, LPNo.7,   Kawasan Perusahaan Suria,Bestari Jaya, Selangor MALAYSIA 45600
   
   
   
    JL.BATANG KUIS GG.TAMBAK REJO DESA BUNTU BEDIMBAR TJ.MORAWA MEDAN, NORTH   SUMATERA, Sumatera Utara INDONESIA 20362
   
   
   
    LOT55, NO.15, JALAN JASMIN 2 BUKIT BERUNTUNG, Selangor MALAYSIA 48300
   
   
   
    LOT 1422-1424, BATU 10 LEKIR SITIAWAN, Perak MALAYSIA 32020
48鉆針深度停止器國械備20250466號ACH   Medical Co., Ltd.28,   Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of   Korea
49拋光工具國械備20190533號OOO"Полировальные   системы"Россия,   175400, Новгородская область, г. Валдай, Крестецкий тупик, д.1
50種植體安裝輔助器械國械備20250465號ACH   Medical Co., Ltd.28,   Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of   Korea
51種植輔助材料國械備20250464號ACH   Medical Co., Ltd.28,   Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of   Korea
52正畸鉗國械備20250463號Ormco   Corporation3232   N Rockwell Street Chicago, IL 60618 USA
53樣本稀釋液國械備20161296號Instrumentation   Laboratory Company526   Route 303 Orangeburg NY 10962 United States Of America
54清洗液國械備20161107號Instrumentation   Laboratory CompanyCan   Male, s/n 08186 Llica d’Amunt, Barcelona Spain
55激發(fā)液國械備20140129號Instrumentation   Laboratory Co.Can   Male,  08186 Llica d’Amunt, Barcelona   Spain
56腹部造口彈性繃帶國械備20250150號Tytex   A/SChemlonská   1,06601 Humenné, Slovakia
57免疫顯色試劑國械備20181025號INOVA   Diagnostics, Inc.9900   Old Grove Road San Diego California 92131 USA
58一次性糞便蛋白提取裝置國械備20210604號INOVA   Diagnostics, Inc.VIA   FLAVIA 122 TRIESTE, Trieste ITALY 34147
59牙用輸送器國械備20191194號DXM   CO.,Ltd.No.1003,11santechnotown   B1dg.,138,11sandong-gu,Goyang-si,Gyonnggi-do,Korea
60樣本稀釋液國械備20180693號Solventum   Japan Innovation Limited9900   Old Grove Road San Diego California 92131 USA
61蛋白提取試劑國械備20210603號DXM   Co., Ltd9900   Old Grove Road San Diego California 92131 USA
62基礎(chǔ)外科手術(shù)器械國械備20250462號ARAMID   INDUSTRIESNOL   MOR,WAZIRABAD ROAD SIALKOT-PAKISTAN
63試模國械備20161915號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
64扳手國械備20161908號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
65螺桿夾持鉗國械備20161788號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
66骨科用螺絲刀國械備20161927號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
67打入器國械備20161909號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
68髖關(guān)節(jié)手術(shù)工具包國械備20190200號JRI   ORTHOPAEDICS LTD18   Churchill Way, 35A Business Park, Chapeltown, Sheffield S35 2PY, UK
69快裝手柄國械備20161916號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
70量規(guī)國械備20161913號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
71拔出器國械備20161917號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
72骨科鉆孔瞄準(zhǔn)器國械備20161928號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
73骨用牽開器國械備20161912號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
74骨鉸刀國械備20161914號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
75骨銼國械備20161926號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
76骨銼國械備20150067號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
77骨鉤國械備20161910號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
78持骨鉗國械備20161787號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
79骨鉆國械備20161925號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
80骨刮匙國械備20161911號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
81骨鑿國械備20161924號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park,Chapeltown, Sheffield, S35 2PY
82骨錐國械備20170210號JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
83牙科種植掃描定位件國械備20181322號Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE
84清洗液國械備20151638號Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim,Germany
85醫(yī)用退熱貼國械備20151768號Solventum   US LLC601   22nd Ave. South Brookings, South Dakota, 57006, USA
86琥珀酸脫氫酶復(fù)合體B亞基(SDHB)抗體試劑(免疫組織化學(xué))國械備20250461號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
87胰島蛋白(Langerin)抗體試劑(免疫組織化學(xué))國械備20250460號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
88 CD123抗體試劑(免疫組織化學(xué))國械備20250459號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
89癌胚抗原(CEA)抗體試劑(免疫組織化學(xué))國械備20250458號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
90LMO2抗體試劑(免疫組織化學(xué))國械備20250457號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
91CD5抗體試劑(免疫組織化學(xué))國械備20250456號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
92乙型肝炎病毒表面抗原(HBsAg)   抗體試劑(免疫組織化學(xué))國械備20250455號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
93細(xì)胞周期蛋白依賴性激酶4(CDK4)抗體試劑(免疫組織化學(xué))國械備20250454號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
94CD21抗體試劑(免疫組織化學(xué))國械備20250453號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
95乙型肝炎核心抗原(HBcAg)抗體試劑(免疫組織化學(xué))國械備20250452號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
96蛋白基因產(chǎn)物9.5(Protein   Gene Product9.5)抗體試劑(免疫組織化學(xué))國械備20250451號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
97腺病毒(Adenovirus)抗體試劑(免疫組織化學(xué))國械備20250450號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
98基礎(chǔ)外科手術(shù)器械 國械備20210455號Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland
99神經(jīng)和心血管手術(shù)器械國械備20210436號Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland
100骨科手術(shù)器械國械備20210435號Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland
101研光器國械備20170116號Kerr   Italia S.r.l.Via   Strecce 4 P.O. 272 6934 Bioggio Switzerland
102口腔科器械國械備20240294號Exlin(Pvt)Ltd  Nasir   Road, Near Classico Chowk, Sialkot-51310 - Pakistan 
103運(yùn)送培養(yǎng)基國械備20210229號Copan   Italia S.p.A.Via   F. Perotti 18,25125 Brescia,Italy;Via F. Perotti 10,25125 Brescia,Italy
104運(yùn)送培養(yǎng)基國械備20191277號Copan   Italia S.p.A.Via   F. Perotti 18, 25125 Brescia, Italy;     Via F. Perotti 10, 25125 Brescia, Italy
105一次性使用細(xì)胞過濾采集器國械備20160622號Hologic,Inc.250   Campus Drive, Marlborough, Massachusetts, 01752, USA
106細(xì)胞保存液國械備20160550號Hologic,   Inc.250   Campus Drive, Marlborough, Massachusetts, 01752, USA
107巴氏染色液國械備20150010號Hologic,   Inc.250   Campus Drive, Marlborough, Massachusetts, 01752,USA
108細(xì)胞保存液國械備20140197號Hologic,   Inc.
109一次性使用細(xì)胞過濾采集器國械備20160621號Hologic,Inc.250   Campus Drive, Marlborough, Massachusetts, 01752, USA; 4 Navigator Road,   Londonderry, New Hampshire 03053, USA
110細(xì)胞保存液國械備20140367號Hologic,   Inc.
111細(xì)胞清洗液國械備20140214號Hologic,   Inc.250   Campus Drive, Marlborough, Massachusetts, 01752,USA
112顯微持針鑷國械備20250449號MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A 6020 Innsbruck AUSTRIA
113自動(dòng)加樣系統(tǒng)國械備20240131號Becton,   Dickinson and Company, BD BiosciencesNeuwiesenstrasse   4, 8222 Beringen, Switzerland
114彈性醫(yī)用膠布 國械備20150483 號Solventum   Japan Innovation Limited5500   Ooaza-Osanagi, Higashine-shi, Yamagata, 999-3737 Japan
115CEA抗體試劑(免疫組織化學(xué))國械備20190896號Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark
116全自動(dòng)微生物樣本處理系統(tǒng)國械備20210155號BD   Kiestra B.V.730   Fountain Street - Building 2, Cambridge, ON N3H 4R7, Canada
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