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2025年12月进口第一类医疗器械产品备案信息
发布日期:2026-01-15 00:00浏览次数:79次
来自国家药监局近日披露的数据,2025年12月国家药监局累计批准牙胶充填器、种植辅助材料、凝血分析用稀释液、运送培养基、弹性医用胶布、显微持针镊、口腔科器械、研光器、神经和心血管手术器械、基础外科手术器械等129个进口第一类医疗器械产品备案事项,一起来看具体内容。

来自国家药监局近日披露的数据,2025年12月国家药监局累计批准牙胶充填器、种植辅助材料、凝血分析用稀释液、运送培养基、弹性医用胶布、显微持针镊、口腔科器械、研光器、神经和心血管手术器械、基础外科手术器械等129个进口第一类医疗器械产品备案事项,一起来看具体内容。

进口第一类医疗器械产品备案.jpg

2025年12月进口第一类医疗器械产品备案信息

序号医疗器械产品名称医疗器械备案号备案人名称原文生产地址原文
1橡皮障国械备20220240号Dent4You   AGLot   6, Lorong Bemban 2,Bemban Industrial Park, Batu Gajah Perak,31000, Malaysia;   1245 Home Avenue, Akron, Ohio, 44301, United States
2骨水泥枪国械备20220545号Tecres   S.p.A.Via   Andrea Doria, 6 Sommacampagna (VR) 37066 Italy
3手术用头架国械备20150066号Integra   LifeSciences Corporation4900   Charlemar Dr. Building A, Cincinnati, OH 45227 USA
4颅骨钻国械备20240155号Brainlab   SEOlof-Palme-Stra?e   9, 81829 München,Germany
5导航手术工具国械备20200654号Brainlab   SEOlof-Palme-Stra?e   9, 81829 München,Germany
6增强液国械备20200322号DiaSorin   Italia S.p.A.Von-Hevesy-Str.   3, 63128 Dietzenbach, Germany
7胸腔组织钳国械备20151160号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
8二尖瓣膜拉钩国械备20151161号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
9胸腔止血钳国械备20151162号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
10基础外科手术器械国械备20151337号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
11咬骨钳国械备20151165号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
12心脏手术剪国械备20151164号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
13肋骨合拢器国械备20151152号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
14二尖瓣膜拉钩国械备20151153号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
15胸腔镊国械备20151159号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
16骨用牵开器国械备20151146号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
17颈椎牵开器国械备20151148号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
18腹部手术牵开器国械备20151151号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
19骨科撑开器国械备20151144号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
20倒置生物显微镜国械备20250071号NIKON   CORPORATION471,   NAGAODAI-CHO, SAKAE-KU, YOKOHAMA, KANAGAWA, 244-8533, JAPAN
21倒置生物显微镜国械备20230515号株式会社二コン471,   Nagaodai-Cho, Sakae-Ku, Yokohama, Kanagawa, 244-8533, Japan
22生物显微镜国械备20240266号NIKON   CORPORATION471,   NAGAODAI-CHO, SAKAE-KU, YOKOHAMA, KANAGAWA, 244-8533, JAPAN
23生物显微镜国械备20220063号株式会社二コン244-8533 日本神奈川県横浜市栄区長尾台町471
24口腔观察仪国械备20250476号Dentall   Co., Ltd.301-905,   Bucheon Technopark, 345, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14501,   Republic of Korea
25全自动核酸提取纯化仪国械备20181731号Tecan   Schweiz AGSeestraβe   103, 8708 M?nnedorf, Switzerland
26全自动核酸提取纯化仪国械备20160221号Tecan   Schweiz AGSeestraβe   103, CH-8708 Mannedorf, Switzerland
27双目放大镜国械备20250475号ExamVision   A/SIndustrivej   11, 8305 Samsφ, Denmark
28正畸钳国械备20170044号WORLD   BIO TECH CO., LTD.BizCenter-302,(Sangdaewon-dong,   SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do
29打磨抛光组件国械备20170041号WORLD   BIO TECH CO., LTD.BizCenter-302,(Sangdaewon-dong,   SKn Technopark), 124,Sagimakgol-ro, Jungwon-gu, Seongnam-si,Gyeonggi-do
30义齿修复工具国械备20161964号Zest   Anchors, LLC2230   Enterprise Street, Escondido, California, 92029, USA
31骨科外固定夹板国械备20181768号THUASNE118/120,   rue Marius Aufan BP 243 FR-92307 LEVALLOIS-PERRET
32基础外科手术器械国械备20250474号EKAL   SURGICAL WORKSKashmir   Road, Ismailabad, Pacca Garha, Sialkot - 51310 - Pakistan
33口腔治疗器具国械备20250473号EKAL   SURGICAL WORKSKashmir   Road, Ismailabad, Pacca Garha, Sialkot - 51310 - Pakistan
34口腔治疗器具国械备20250472号BILLU   BROTHERS SURGICAL CO.JEEWAN   PURA, SIALKOT-51310, PAKISTAN
35口腔治疗器具国械备20250471号SOBYTEK   (PRIVATE) LIMITEDRoras   Road, Muzaffar Pur, Sialkot 51310 – Pakistan
36基础外科手术器械国械备20250470号J.R.   BROTHERS SURGICAL INSTRUMENTS Incorporating the NOMI INDUSTRIES BrandP.O.   Box 1195 Near Peer Hara, Harrar, Sialkot Pakistan
37牙科角度尺国械备20250469号Ivoclar   Vivadent AGBendererstrasse   2, 9494 Schaan, LIECHTENSTEIN;Bremschlstrasse 16, 6706 Bürs, AUSTRIA
38Kappa链抗体试剂(免疫组织化学)国械备20180643号Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA
39过碘酸雪夫染色液(糖原染色液,PAS) 国械备20250170号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA
40显微外科手术器械国械备20151338号Best   medical GmbHHeudorferstrasse   32 D-78576 Emmingen-Liptingen
41去血片洗板机国械备20200542号Wallac   Oy7   rue de Madrid , 67300 SCHILTIGHEIM, FRANCE
42一次性使用唾液采集器国械备20230045号DNA   Genotek Inc.3000   - 500 Palladium Drive; Ottawa, ON; K2V1C2 CANADA
43牙科种植体通用取出工具包国械备20250468号Neobiotech   Co., Ltd.70,   Sinpyeong-ro, Jijeong-myeon, Wonju-si, Gangwon-do, Republic of Korea
44牙科抛光磨头国械备20250467号EVE   Ernst Vetter GmbHNeureutstra?e   6 75210 Keltern Germany
45样本稀释液国械备20200454号The   Binding Site Group Ltd8   Calthorpe Road Edgbaston Birmingham B15 1QT United Kingdom
46检查手套国械备20170721号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检查手套国械备20170722号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钻针深度停止器国械备20250466号ACH   Medical Co., Ltd.28,   Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of   Korea
49抛光工具国械备20190533号OOO"Полировальные   системы"Россия,   175400, Новгородская область, г. Валдай, Крестецкий тупик, д.1
50种植体安装辅助器械国械备20250465号ACH   Medical Co., Ltd.28,   Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of   Korea
51种植辅助材料国械备20250464号ACH   Medical Co., Ltd.28,   Namyang-ro 930beon-gil, Namyang-eup, Hwaseong-si, Gyeonggi-do, Republic of   Korea
52正畸钳国械备20250463号Ormco   Corporation3232   N Rockwell Street Chicago, IL 60618 USA
53样本稀释液国械备20161296号Instrumentation   Laboratory Company526   Route 303 Orangeburg NY 10962 United States Of America
54清洗液国械备20161107号Instrumentation   Laboratory CompanyCan   Male, s/n 08186 Llica d’Amunt, Barcelona Spain
55激发液国械备20140129号Instrumentation   Laboratory Co.Can   Male,  08186 Llica d’Amunt, Barcelona   Spain
56腹部造口弹性绷带国械备20250150号Tytex   A/SChemlonská   1,06601 Humenné, Slovakia
57免疫显色试剂国械备20181025号INOVA   Diagnostics, Inc.9900   Old Grove Road San Diego California 92131 USA
58一次性粪便蛋白提取装置国械备20210604号INOVA   Diagnostics, Inc.VIA   FLAVIA 122 TRIESTE, Trieste ITALY 34147
59牙用输送器国械备20191194号DXM   CO.,Ltd.No.1003,11santechnotown   B1dg.,138,11sandong-gu,Goyang-si,Gyonnggi-do,Korea
60样本稀释液国械备20180693号Solventum   Japan Innovation Limited9900   Old Grove Road San Diego California 92131 USA
61蛋白提取试剂国械备20210603号DXM   Co., Ltd9900   Old Grove Road San Diego California 92131 USA
62基础外科手术器械国械备20250462号ARAMID   INDUSTRIESNOL   MOR,WAZIRABAD ROAD SIALKOT-PAKISTAN
63试模国械备20161915号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
64扳手国械备20161908号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
65螺杆夹持钳国械备20161788号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
66骨科用螺丝刀国械备20161927号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
67打入器国械备20161909号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
68髋关节手术工具包国械备20190200号JRI   ORTHOPAEDICS LTD18   Churchill Way, 35A Business Park, Chapeltown, Sheffield S35 2PY, UK
69快装手柄国械备20161916号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
70量规国械备20161913号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
71拔出器国械备20161917号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
72骨科钻孔瞄准器国械备20161928号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
73骨用牵开器国械备20161912号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
74骨铰刀国械备20161914号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
75骨锉国械备20161926号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
76骨锉国械备20150067号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
77骨钩国械备20161910号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
78持骨钳国械备20161787号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
79骨钻国械备20161925号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
80骨刮匙国械备20161911号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
81骨凿国械备20161924号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park,Chapeltown, Sheffield, S35 2PY
82骨锥国械备20170210号JRI   ORTHOPAEDICS LIMITED18   Churchill Way, 35A Business Park Chapeltown, Sheffield, S35 2PY
83牙科种植扫描定位件国械备20181322号Anthogyr   SAS2237   avenue André Lasquin, 74700 SALLANCHES FRANCE
84清洗液国械备20151638号Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim,Germany
85医用退热贴国械备20151768号Solventum   US LLC601   22nd Ave. South Brookings, South Dakota, 57006, USA
86琥珀酸脱氢酶复合体B亚基(SDHB)抗体试剂(免疫组织化学)国械备20250461号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
87胰岛蛋白(Langerin)抗体试剂(免疫组织化学)国械备20250460号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
88 CD123抗体试剂(免疫组织化学)国械备20250459号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
89癌胚抗原(CEA)抗体试剂(免疫组织化学)国械备20250458号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
90LMO2抗体试剂(免疫组织化学)国械备20250457号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
91CD5抗体试剂(免疫组织化学)国械备20250456号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
92乙型肝炎病毒表面抗原(HBsAg)   抗体试剂(免疫组织化学)国械备20250455号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
93细胞周期蛋白依赖性激酶4(CDK4)抗体试剂(免疫组织化学)国械备20250454号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
94CD21抗体试剂(免疫组织化学)国械备20250453号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
95乙型肝炎核心抗原(HBcAg)抗体试剂(免疫组织化学)国械备20250452号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
96蛋白基因产物9.5(Protein   Gene Product9.5)抗体试剂(免疫组织化学)国械备20250451号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
97腺病毒(Adenovirus)抗体试剂(免疫组织化学)国械备20250450号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
98基础外科手术器械 国械备20210455号Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland
99神经和心血管手术器械国械备20210436号Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland
100骨科手术器械国械备20210435号Cardio   Surgical Ltd.Clogan,   Stradbally North ,Clarinbridge , Co Galway H91 Y9C9, Ireland
101研光器国械备20170116号Kerr   Italia S.r.l.Via   Strecce 4 P.O. 272 6934 Bioggio Switzerland
102口腔科器械国械备20240294号Exlin(Pvt)Ltd  Nasir   Road, Near Classico Chowk, Sialkot-51310 - Pakistan 
103运送培养基国械备20210229号Copan   Italia S.p.A.Via   F. Perotti 18,25125 Brescia,Italy;Via F. Perotti 10,25125 Brescia,Italy
104运送培养基国械备20191277号Copan   Italia S.p.A.Via   F. Perotti 18, 25125 Brescia, Italy;     Via F. Perotti 10, 25125 Brescia, Italy
105一次性使用细胞过滤采集器国械备20160622号Hologic,Inc.250   Campus Drive, Marlborough, Massachusetts, 01752, USA
106细胞保存液国械备20160550号Hologic,   Inc.250   Campus Drive, Marlborough, Massachusetts, 01752, USA
107巴氏染色液国械备20150010号Hologic,   Inc.250   Campus Drive, Marlborough, Massachusetts, 01752,USA
108细胞保存液国械备20140197号Hologic,   Inc.
109一次性使用细胞过滤采集器国械备20160621号Hologic,Inc.250   Campus Drive, Marlborough, Massachusetts, 01752, USA; 4 Navigator Road,   Londonderry, New Hampshire 03053, USA
110细胞保存液国械备20140367号Hologic,   Inc.
111细胞清洗液国械备20140214号Hologic,   Inc.250   Campus Drive, Marlborough, Massachusetts, 01752,USA
112显微持针镊国械备20250449号MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A 6020 Innsbruck AUSTRIA
113自动加样系统国械备20240131号Becton,   Dickinson and Company, BD BiosciencesNeuwiesenstrasse   4, 8222 Beringen, Switzerland
114弹性医用胶布 国械备20150483 号Solventum   Japan Innovation Limited5500   Ooaza-Osanagi, Higashine-shi, Yamagata, 999-3737 Japan
115CEA抗体试剂(免疫组织化学)国械备20190896号Agilent   Technologies Singapore (International) Pte Ltd.Produktionsvej   42, DK-2600 Glostrup, Denmark
116全自动微生物样本处理系统国械备20210155号BD   Kiestra B.V.730   Fountain Street - Building 2, Cambridge, ON N3H 4R7, Canada
117生物显微镜国械备20250354号株式会社エビデント長野県上伊那郡辰野町大字伊那富6666番地
118血压袖带国械备20151703号日本光電工業株式会社千葉県市原市八幡海岸通1969-33、34
119核酸提取或纯化试剂国械备20181608号QIAGEN   GmbHQIAGEN   Strasse 1, 40724 Hilden , Germany
120人疱疹病毒4型(EBV)抗体试剂(免疫组织化学)国械备20250448号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA
121低离子强度盐溶液 国械备20151461号Immucor,   Inc.3130   Gateway Drive, Norcross, Georgia 30071,USA
122血型分析用稀释液国械备20140074号Immucor,   Inc.3130   Gateway Drive, Norcross, Georgia 30071, USA
123牙科修整用金刚砂车针国械备20250447号best   medical GmbHHeudorfer   Straβe 32 78576 Emmingen-Liptingen Germany
124运送培养基国械备20170237号Copan   Italia S.p.a.Via   F. Perotti, 10, 25125 Brescia, Italy
125运送培养基国械备20191312号Copan   Italia S.p.A.Via   F. Perotti 18, 25125 Brescia, Italy; Via F. Perotti 10, 25125 Brescia, Italy
126瓣膜夹及导管输送系统的支撑固定附件国械备20250446号Abbott   Medical3885   Bohannon Drive Menlo Park California 94025 USA
127种植辅助材料国械备20170167号Institut   Straumann AGPeter   Merian-Weg 12,4002 Basel,Switzerland; Les Champs du Clos 2,2613   Villeret,Switzerland; 60 Minuteman Road,Andover,MA,01810,USA
128凝血分析用稀释液国械备20161294号Instrumentation   Laboratory Company526   Route 303 Orangeburg NY 10962 United States Of America
129牙胶充填器国械备20171262号DXM   Co., LtdNo   . 1003, llsantechnotown Bldg.,138, llsan -ro, llsandong-gu,   Goyang-si,Gyeonggi-do, Korea 

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