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当前位置：网站首页>新闻动态 >国家局2025年8月批准122项进口第一类医疗器械产品备案
国家局2025年8月批准122项进口第一类医疗器械产品备案
发布日期:2025-09-10 00:00浏览次数:78次
今天是教师节，是一个对我国全体教育工作者感恩的美好日子。在文章开头，在这个特别的日子，祝老师们节日快乐。来自国家药监局2025年9月10日消息，2025年8月，国家要药监局批准耳镜、医用放大镜、医用高分子夹板、CD45抗体试剂、人类白细胞抗原DR抗体试剂等122项进口第一类医疗器械产品备案，一起来看具体内容。

今天是教师节，是一个对我国全体教育工作者感恩的美好日子。在文章开头，在这个特别的日子，祝老师们节日快乐。来自国家药监局2025年9月10日消息，2025年8月，国家要药监局批准耳镜、医用放大镜、医用高分子夹板、CD45抗体试剂、人类白细胞抗原DR抗体试剂等122项进口第一类医疗器械产品备案，一起来看具体内容。

进口第一类医疗器械产品备案.jpg

国家局2025年8月批准122项进口第一类医疗器械产品备案信息

序号产品名称备案号备案人名称原文生产地址原文备案日期
1耳镜国械备20200119号精國醫療器材有限公司新北市蘆洲區國道路二段68號2樓2025-08-29 
2医用放大镜国械备20240380号Bryant   Medical Ltd t/a Bryant DentalThe   Barns, Hilltop Farm, Lyne Lane, Chertsey, KT16 0AW, Surrey, United Kingdom2025-08-28 
3医用高分子夹板国械备20181577号OKM   QUIMICA ORTOPEDICA,S.L.CTRA.,N-260,KM.41,POL.IND.LA   TIMBA, NAVE 1,17742 AVINYONET DE PUIGVENTOS (GERONA)2025-08-28 
4CD45抗体试剂国械备20250307号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
5人类白细胞抗原DR抗体试剂国械备20250306号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
6CD8抗体试剂国械备20250305号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
7CD13抗体试剂国械备20250304号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
8CD33抗体试剂国械备20250303号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
9髓过氧化物酶（MPO）抗体试剂国械备20250302号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
10CD4抗体试剂国械备20250301号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
11CD117抗体试剂国械备20250300号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
12CD79a抗体试剂国械备20250299号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
13CD56抗体试剂国械备20250298号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
14CD123抗体试剂国械备20250297号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
15CD4抗体试剂国械备20250296号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
16CD5抗体试剂国械备20250295号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
17CD4抗体试剂国械备20250294号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
18CD5抗体试剂国械备20250293号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
19CD38抗体试剂国械备20250292号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
20CD13抗体试剂国械备20250291号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
21CD45抗体试剂国械备20250290号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
22CD33抗体试剂国械备20250289号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
23CD3抗体试剂国械备20250288号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
24CD79a抗体试剂国械备20250287号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
25CD3抗体试剂国械备20250286号Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
26医用固定带国械备20190635号達豫醫療器材股份有限公司彰化縣田中鎮新工三路123號2025-08-27 
27染色机国械备20140016号Leica   Biosystems Melbourne Pty Ltd495   Blackburn Road Mt Waverley Victoria 3149 Australia2025-08-22 
28染色机国械备20140277号Leica   Biosystems Melbourne Pty Ltd495   Blackburn Road Mt Waverley Victoria 3149 Australia2025-08-22 
29成形片夹国械备20250285号POLYDENTIA   SAVia   Cantonale, 47-CH 6805 Mezzovico-Vira(Svizzera)2025-08-22 
30牙科成形片器械包国械备20250284号POLYDENTIA   SAVia   Cantonale,47-CH6805 Mezzovico-Vira(Svizzera)2025-08-22 
31牙科隔离及赋形材料器械包国械备20250283号POLYDENTIA   SAVia   Cantonale, 47-CH 6805 Mezzovico-Vira(Svizzera)2025-08-22 
32基础外科手术器械国械备20250282号Next   Instruments410/E,   Khadim Ali Road, Sialkot-51310-Pakistan2025-08-21 
33基础外科手术器械国械备20250281号MODERN   SURGICAL CORPORATIONTarrar   Street, Mohallah Umer Town, Defence Road, Sialkot, Pakistan2025-08-21 
34口腔治疗器具国械备20250280号LB   INSTRUMENTS PVT (LTD.)10   KM Daska Road, Near City Housing, Sialkot, Pakistan, 514102025-08-21 
35缓冲液国械备20250279号Siemens   Healthcare Diagnostics Products GmbHEmil   von Behring Str.76 35041 Marburg Germany2025-08-21 
36六胺银染色液国械备20161977号Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2025-08-21 
37HMB-45抗体试剂（免疫组织化学）国械备20180600号Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2025-08-21 
38MART-1/melan   A抗体试剂（免疫组织化学）国械备20180595号Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2025-08-21 
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, USA2025-08-21 
40p63抗体试剂（免疫组织化学）国械备20190039号Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2025-08-21 
41p120抗体试剂（免疫组织化学）国械备20180248号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2025-08-21 
42血型分析用稀释液国械备20250278号Ortho-Clinical   Diagnostics1001   US Highway 202, Raritan NJ 08869, USA2025-08-21 
43p40抗体试剂（免疫组织化学）国械备20240237号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-08-21 
44胰岛素瘤相关蛋白1（INSM1）抗体试剂（免疫组织化学法）国械备20250277号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive,  Tucson AZ   85755, USA2025-08-21 
45Calretinin抗体试剂（免疫组织化学）国械备20180435号Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2025-08-21 
46螺丝起国械备20250276号Hiossen,   Inc.85   Ben Fairless Drive, Fairless Hills, PA, 19030, USA2025-08-20 
47医用检查手套国械备20190299号A   R MEDICOM (M) SDN BHD3RD   FLOOR, WISMA KOON HOE, NO.3 JALAN 13/3, 46200 PETALING JAYA, SELANGOR DARUL   EHSAN, MALAYSIA2025-08-19 
48医用检查手套国械备20181202号A   R Medicom (M) Sdn BhdSuite   807, Block A, Kelana Centre Point, 3, Jalan SS7/19, 47301 Petaling Jaya,   Selangor, MALAYSIA2025-08-19 
49种植体安装辅助器械国械备20250275号radix   Implants & Biomaterials GmbHHirzenrott   2-4 52076 Aachen Germany2025-08-19 
50医用检查手套国械备20200132号Mexpo   International Inc.Lot   4969,Jalan Teratai, Batu 6, Off Jalan Meru,41050 Klang, Selangor Darul Ehsan,   Malaysia2025-08-19 
51印模帽国械备20250274号Dentium   Co., Ltd.???   ??? ??? ????256?? 76, 3F, 4F??, 6F(???)2025-08-19 
52医用超声波清洗器国械备20250233号Getinge   Disinfection ABLjungadalsgatan   11, 352 46 V?xj?, SWEDEN2025-08-19 
53MUM1抗体试剂国械备20250273号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
54胶质纤维酸性蛋白（GFAP）抗体试剂国械备20250272号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
55细胞角蛋白7（CK7）抗体试剂国械备20250271号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
56黏蛋白4（MUC-4）抗体试剂国械备20250270号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
57细胞角蛋白19（CK19）抗体试剂国械备20250269号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
58雄激素受体（AR）抗体试剂国械备20250268号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
59CD31抗体试剂国械备20250267号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
60牙科修整用不锈钢车针国械备20250266号マニー株式会社栃木県塩谷郡高根沢町中阿久津743；Vang   Residential Group，Tan Huong Ward，Pho Yen City，Thai Nguyen Province，Vietnam2025-08-18 
61样本稀释液国械备20191036号Hologic,   Inc.Oaks   Business Park Crewe Road, Wythenshawe Manchester M23 9HZ UNITED KINGDOM2025-08-18 
62病理石蜡包埋机国械备20171072号Hologic,   Inc.445   Simarano Drive, Marlborough, MA 01752, USA2025-08-18 
63样本萃取液国械备20191035号Hologic,   Inc.10210   Genetic Center Drive, San Diego, CA 92121 UNITED STATES2025-08-18 
64牵开器  国械备20191068号ASANUS   Medizintechnik GmbHtake   off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2025-08-18 
65H3K27M抗体试剂国械备20250265号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
66生长激素因子-1（PIT-1）抗体试剂国械备20250264号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
67H3K36M抗体试剂国械备20250263号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
68Uroplakin   Ⅱ抗体试剂国械备20250262号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
69睾丸核蛋白（NUT）抗体试剂国械备20250261号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
70H3.3G34W抗体试剂国械备20250260号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
71牙科种植手术器械包国械备20250259号FIMS   Co., Ltd.????,   ??? ??? ??? ???? 256??76, 4F??2025-08-18 
72CD3抗体试剂国械备20250258号Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-15 
73漏斗胸手术器械包国械备20250257号Biomet   Microfixation1520   Tradeport Drive Jacksonville Florida 32218 USA； 56 East Bell Drive, P.O.Box   587 Warsaw Indiana USA 465812025-08-15 
74咬合纸国械备20250256号Directa   ABFinvids   v?g 8, SE-194 47 Upplands V?sby, Sweden2025-08-15 
75超声探头穿刺架国械备20180422号CIVCO   Medical Instruments Co.,Inc.102   FIRST ST.SOUTH Kalona, IA USA 522472025-08-15 
76超声探头穿刺架国械备20180216号CIVCO   Medical Instruments Co.,Inc.102   FIRST ST.SOUTH Kalona, IA USA 522472025-08-15 
77超声探头穿刺架国械备20181495号CIVCO   Medical Instruments Co., Inc.102   FIRST ST. SOUTH, Kalona, IA USA 52247
   
   		2025-08-15 
78医用清洗器国械备20181353号CIVCO   Medical Instruments Co., Inc.102   FIRST ST. SOUTH Kalona, IA USA 522472025-08-15 
79超声探头穿刺架国械备20180055号CIVCO   Medical Instruments Co.,Inc.102   FIRST ST.SOUTH Kalona, IA USA 522472025-08-15 
80染色机国械备20160156号Hologic，Inc.250   Campus Drive Marlborough Massachusetts 01752 USA/1750a Costner   Dr.Warrington,PA 18976 USA2025-08-13 
81全自动样本处理及孵育系统国械备20160837号Hologic,Inc.16990   Goldentop Road, San Diego, CA 92127, United States2025-08-13 
82一次性使用细胞过滤采集器国械备20160620号Hologic,   Inc.250   Campus Drive, Marlborough, Massachusetts, 01752, USA; 4 Navigator Road,   Londonderry, New Hampshire 03053, USA2025-08-13 
83牙用测力计国械备20250255号Kube   Innovation Inc.5524   rue Saint-Patrick, Suite 315 Montréal, Quebec, H4E 1A8, Canada2025-08-13 
84腹透管路夹国械备20151519号Vantive   Health GmbHFoxford   Road, Swinford, CO.Mayo, IRELAND2025-08-13 
85种植体扫描体国械备20180660号Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2025-08-12 
86替代体国械备20181382号Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2025-08-12 
87口腔科手术器械国械备20250248号LATNED   DENTALHead,Marala   Road, Machikhokhar Sialkot Pakistan.2025-08-12 
88口外研磨材料国械备20250254号Medifive   Co., Ltd.324,   Korea Industrial Complex, 84, Namdongdong-ro, Namdong-gu, Incheon, Republic   of Korea2025-08-12 
89粪便检验预处理装置国械备20250253号Apacor   Limited Sapphire   Centre, Fishponds Road, Wokingham Berkshire RG41 2QL United Kingdom.2025-08-12 
90口腔科手术器械国械备20250252号ENGRAVO   SURGICOAzmat   Lodge,Moh,Hassan Pura,Gulshan Town,Sialkot,Pakistan2025-08-12 
91马镫形多功能腿架国械备20160568号Herbert（Thailand）Co.,   Ltd.47   Moo 1  Mitraphap Road, Tambon Samran,   Amphur Muang, Khon Kaen 40000, Thailand2025-08-12 
92夹持器国械备20181256号株式会社システム?ジェーピー静岡県浜松市東区下石田町1025番地の12025-08-12 
93马镫形多功能腿架国械备20180217号Herbert   （Thailand）Co., Ltd47   Moo 1 Mitraphap Road，Tambon Samran，Amphur Muang，Khon Kaen 40000，Thailand2025-08-12 
94马镫形多功能腿架国械备20180218号Herbert   （Thailand）Co.，Ltd.47   Moo 1 Mitraphap Road，Tambon Samran，Amphur Muang，Khon Kaen 40000，Thailand2025-08-12 
95医用射线防护用具国械备20210326号WSR   Medical Solutions LTDUnit   E Bridgewater Close, Network 65 Business Park, Hapton,Burnley, BB11 5TE2025-08-12 
96负压吸引用收集装置国械备20190592号Medela   AG L?ttichstrasse   4b, 6340 Baar, Switzerland2025-08-11 
97骨传导植入式听力系统植入手术器械包国械备20210449号Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2025-08-11 
98骨传导植入式听力系统植入手术器械包国械备20210423号Cochlear   Bone Anchored Solutions ABKonstruktionsvagen   14, SE-435 33 Molnlycke, Sweden2025-08-11 
99骨传导植入式听力系统植入手术器械包国械备20190728号Cochlear   Bone Anchored Solutions ABKonstruktionsvagen   14, SE-435 33 Molnlycke, Sweden2025-08-11 
100牵开器国械备20250251号medical   bees GmbHFriedrich-W?hler-Stra?e   13 78576 Emmingen Germany2025-08-11 
101样本稀释液国械备20250058号Roche   Diagnostics GmbHNonnenwald   2, 82377 Penzberg, GERMANY2025-08-11 
102医用检查手套国械备20250250号UG   GLOBAL RESOURCES SDN. BHD.Lot   62 & 63, Lorong Senawang 3/2,Kawasan Perindustrian Senawang, 70450   Seremban, Negeri Sembilan Darul Khusus, Malaysia2025-08-11 
103医用压敏胶带国械备20250249号????? ???   ??? ??? ??? ???291?? 742025-08-08 
104试模国械备20140363号Smith   & Nephew Orthopaedics AGSchachenallee   29,5001 Aarau, Switzerland; Dammweg 39,5001 Aarau, Switzerland2025-08-08 
105髋关节手术器械国械备20161805号Smith   & Nephew Orthopaedics AGSchachenalle   29,5001 Aarau, Switzerland;
   
    Dammweg 39,5001 Aarau, Switzerland;
   
    Oberneuhofstrasse 10a, 6340 Baar, Switzerland;
   
    Boulevard Héctor Terán #20120, Ciudad Industrial, Tijuana, B.C.22444,   Mexico.
   
    Ul.Stanislawa Staszica 555-011 Siechnice Polen;
   
    Grünauer Fenn 3, 14712 Rathenow, Germany		2025-08-07 
106干式激光成像仪国械备20151260号コニカミノルタ株式会社埼玉県狭山市広瀬台二丁目2番1号　2-2-1，   Hirosedai，Sayama-shi，Saitama2025-08-07 
107医用体位胶垫国械备20140329号????   ???? ????无2025-08-07 
108压力绷带国械备20180201号Medi   GmbH & Co.KGMedicusstraβe   1, 95448 Bayreuth, Germany2025-08-07 
109干式激光成像仪国械备20170398号コニカミノルタ株式会社1   Sakura-machi，Hino-shi，Tokyo，Japan；2-2-1，   Hirosedai，Sayama-shi，Saitama，Japan 2025-08-06 
110口腔科手术器械国械备20250248号LATNED   DENTALHead,Marala   Road, Machikhokhar Sialkot Pakistan.2025-08-05 
111医用外固定支具国械备20170130号THUASNE118/120,   rue Marius Aufan BP 243 FR-92307 LEVALLOIS-PERRET; 4615 Shepard St.   Bakersfield, CA 93313;Im Steinkamp 12, 30938 Burgwedel 2025-08-05 
112弹性绷带国械备20171074号CIZETA   MEDICALI S.P.A.Via   IV Novembre,46-20012 CUGGIONO(MI)-ITALY2025-08-04 
113口腔科器械国械备20240396号A.Schweickhardt   GmbH＆Co.KGTuttlinger   Straβe 12 78606 Seitingen-Oberflacht Germany2025-08-04 
114牙科骨磨国械备20230091号A.Schweickhardt   GmbH & Co.KGTuttlinger   Stra?e 12 78606 Seitingen/ Tuttlingen Germany2025-08-04 
115口腔科器械国械备20191336号A.Schweickhardt   GmbH＆Co.KGTuttlinger   Stra?e 12 78606 Seitingen / Tuttlingen Germany2025-08-04 
116骨铰刀国械备20250247号Gebr.   Brasseler GmbH & Co. KGTrophagener   Weg 25 32657 Lemgo Germany2025-08-04 
117自动制片机国械备20151734号Hologic，Inc.445   Simarano Drive, Marlborough, MA 01752 USA2025-08-04 
118清洗液国械备20191034号Hologic,   Inc.10210   Genetic Center Drive, San Diego, CA 92121 UNITED STATES2025-08-04 
119半月板缝合修复手术器械（包）国械备20250246号ConMed   Corporation11311   Concept Boulevard, Largo, FL 33773, USA2025-08-04 
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