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國家局2025年8月批準122項進口第一類醫(yī)療器械產(chǎn)品備案
發(fā)布日期:2025-09-10 00:00瀏覽次數(shù):27次
今天是教師節(jié)，是一個對我國全體教育工作者感恩的美好日子。在文章開頭，在這個特別的日子，祝老師們節(jié)日快樂。來自國家藥監(jiān)局2025年9月10日消息，2025年8月，國家要藥監(jiān)局批準耳鏡、醫(yī)用放大鏡、醫(yī)用高分子夾板、CD45抗體試劑、人類白細胞抗原DR抗體試劑等122項進口第一類醫(yī)療器械產(chǎn)品備案，一起來看具體內(nèi)容。

今天是教師節(jié)，是一個對我國全體教育工作者感恩的美好日子。在文章開頭，在這個特別的日子，祝老師們節(jié)日快樂。來自國家藥監(jiān)局2025年9月10日消息，2025年8月，國家要藥監(jiān)局批準耳鏡、醫(yī)用放大鏡、醫(yī)用高分子夾板、CD45抗體試劑、人類白細胞抗原DR抗體試劑等122項進口第一類醫(yī)療器械產(chǎn)品備案，一起來看具體內(nèi)容。

進口第一類醫(yī)療器械產(chǎn)品備案.jpg

國家局2025年8月批準122項進口第一類醫(yī)療器械產(chǎn)品備案信息

序號產(chǎn)品名稱備案號備案人名稱原文生產(chǎn)地址原文備案日期
1耳鏡國械備20200119號精國醫(yī)療器材有限公司新北市蘆洲區(qū)國道路二段68號2樓2025-08-29 
2醫(yī)用放大鏡國械備20240380號Bryant   Medical Ltd t/a Bryant DentalThe   Barns, Hilltop Farm, Lyne Lane, Chertsey, KT16 0AW, Surrey, United Kingdom2025-08-28 
3醫(yī)用高分子夾板國械備20181577號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抗體試劑國械備20250307號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
5人類白細胞抗原DR抗體試劑國械備20250306號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
6CD8抗體試劑國械備20250305號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
7CD13抗體試劑國械備20250304號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
8CD33抗體試劑國械備20250303號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
9髓過氧化物酶（MPO）抗體試劑國械備20250302號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
10CD4抗體試劑國械備20250301號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
11CD117抗體試劑國械備20250300號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
12CD79a抗體試劑國械備20250299號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
13CD56抗體試劑國械備20250298號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
14CD123抗體試劑國械備20250297號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
15CD4抗體試劑國械備20250296號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
16CD5抗體試劑國械備20250295號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
17CD4抗體試劑國械備20250294號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
18CD5抗體試劑國械備20250293號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
19CD38抗體試劑國械備20250292號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
20CD13抗體試劑國械備20250291號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
21CD45抗體試劑國械備20250290號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
22CD33抗體試劑國械備20250289號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
23CD3抗體試劑國械備20250288號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
24CD79a抗體試劑國械備20250287號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
25CD3抗體試劑國械備20250286號Sysmex   Partec GmbHNad   Safinou II 341, 252 50 Vestec, Czech Republic2025-08-28 
26醫(yī)用固定帶國械備20190635號達豫醫(yī)療器材股份有限公司彰化縣田中鎮(zhèn)新工三路123號2025-08-27 
27染色機國械備20140016號Leica   Biosystems Melbourne Pty Ltd495   Blackburn Road Mt Waverley Victoria 3149 Australia2025-08-22 
28染色機國械備20140277號Leica   Biosystems Melbourne Pty Ltd495   Blackburn Road Mt Waverley Victoria 3149 Australia2025-08-22 
29成形片夾國械備20250285號POLYDENTIA   SAVia   Cantonale, 47-CH 6805 Mezzovico-Vira(Svizzera)2025-08-22 
30牙科成形片器械包國械備20250284號POLYDENTIA   SAVia   Cantonale,47-CH6805 Mezzovico-Vira(Svizzera)2025-08-22 
31牙科隔離及賦形材料器械包國械備20250283號POLYDENTIA   SAVia   Cantonale, 47-CH 6805 Mezzovico-Vira(Svizzera)2025-08-22 
32基礎(chǔ)外科手術(shù)器械國械備20250282號Next   Instruments410/E,   Khadim Ali Road, Sialkot-51310-Pakistan2025-08-21 
33基礎(chǔ)外科手術(shù)器械國械備20250281號MODERN   SURGICAL CORPORATIONTarrar   Street, Mohallah Umer Town, Defence Road, Sialkot, Pakistan2025-08-21 
34口腔治療器具國械備20250280號LB   INSTRUMENTS PVT (LTD.)10   KM Daska Road, Near City Housing, Sialkot, Pakistan, 514102025-08-21 
35緩沖液國械備20250279號Siemens   Healthcare Diagnostics Products GmbHEmil   von Behring Str.76 35041 Marburg Germany2025-08-21 
36六胺銀染色液國械備20161977號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson, AZ 85755 USA2025-08-21 
37HMB-45抗體試劑（免疫組織化學(xué)）國械備20180600號Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2025-08-21 
38MART-1/melan   A抗體試劑（免疫組織化學(xué)）國械備20180595號Ventana   Medical Systems, Inc.1910   E. Innovation Park Drive, Tucson, AZ, 85755, USA2025-08-21 
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, USA2025-08-21 
40p63抗體試劑（免疫組織化學(xué)）國械備20190039號Ventana   Medical Systems, Inc.1910E.Innovation   Park Drive Tucson,Arizona 85755 USA2025-08-21 
41p120抗體試劑（免疫組織化學(xué)）國械備20180248號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2025-08-21 
42血型分析用稀釋液國械備20250278號Ortho-Clinical   Diagnostics1001   US Highway 202, Raritan NJ 08869, USA2025-08-21 
43p40抗體試劑（免疫組織化學(xué)）國械備20240237號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson AZ 85755, USA2025-08-21 
44胰島素瘤相關(guān)蛋白1（INSM1）抗體試劑（免疫組織化學(xué)法）國械備20250277號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive,  Tucson AZ   85755, USA2025-08-21 
45Calretinin抗體試劑（免疫組織化學(xué)）國械備20180435號Ventana   Medical Systems, Inc.1910   East Innovation Park Drive, Tucson, AZ, 85755, United States2025-08-21 
46螺絲起國械備20250276號Hiossen,   Inc.85   Ben Fairless Drive, Fairless Hills, PA, 19030, USA2025-08-20 
47醫(yī)用檢查手套國械備20190299號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醫(yī)用檢查手套國械備20181202號A   R Medicom (M) Sdn BhdSuite   807, Block A, Kelana Centre Point, 3, Jalan SS7/19, 47301 Petaling Jaya,   Selangor, MALAYSIA2025-08-19 
49種植體安裝輔助器械國械備20250275號radix   Implants & Biomaterials GmbHHirzenrott   2-4 52076 Aachen Germany2025-08-19 
50醫(yī)用檢查手套國械備20200132號Mexpo   International Inc.Lot   4969,Jalan Teratai, Batu 6, Off Jalan Meru,41050 Klang, Selangor Darul Ehsan,   Malaysia2025-08-19 
51印模帽國械備20250274號Dentium   Co., Ltd.???   ??? ??? ????256?? 76, 3F, 4F??, 6F(???)2025-08-19 
52醫(yī)用超聲波清洗器國械備20250233號Getinge   Disinfection ABLjungadalsgatan   11, 352 46 V?xj?, SWEDEN2025-08-19 
53MUM1抗體試劑國械備20250273號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
54膠質(zhì)纖維酸性蛋白（GFAP）抗體試劑國械備20250272號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
55細胞角蛋白7（CK7）抗體試劑國械備20250271號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
56黏蛋白4（MUC-4）抗體試劑國械備20250270號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
57細胞角蛋白19（CK19）抗體試劑國械備20250269號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
58雄激素受體（AR）抗體試劑國械備20250268號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
59CD31抗體試劑國械備20250267號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-19 
60牙科修整用不銹鋼車針國械備20250266號マニー株式會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樣本稀釋液國械備20191036號Hologic,   Inc.Oaks   Business Park Crewe Road, Wythenshawe Manchester M23 9HZ UNITED KINGDOM2025-08-18 
62病理石蠟包埋機國械備20171072號Hologic,   Inc.445   Simarano Drive, Marlborough, MA 01752, USA2025-08-18 
63樣本萃取液國械備20191035號Hologic,   Inc.10210   Genetic Center Drive, San Diego, CA 92121 UNITED STATES2025-08-18 
64牽開器  國械備20191068號ASANUS   Medizintechnik GmbHtake   off Gewerbepark 2, 78579 Neuhausen ob Eck, Germany2025-08-18 
65H3K27M抗體試劑國械備20250265號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
66生長激素因子-1（PIT-1）抗體試劑國械備20250264號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
67H3K36M抗體試劑國械備20250263號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
68Uroplakin   Ⅱ抗體試劑國械備20250262號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
69睪丸核蛋白（NUT）抗體試劑國械備20250261號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
70H3.3G34W抗體試劑國械備20250260號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-18 
71牙科種植手術(shù)器械包國械備20250259號FIMS   Co., Ltd.????,   ??? ??? ??? ???? 256??76, 4F??2025-08-18 
72CD3抗體試劑國械備20250258號Cell   Marque Corporation6600   Sierra College Blvd. Rocklin, CA 95677 USA2025-08-15 
73漏斗胸手術(shù)器械包國械備20250257號Biomet   Microfixation1520   Tradeport Drive Jacksonville Florida 32218 USA； 56 East Bell Drive, P.O.Box   587 Warsaw Indiana USA 465812025-08-15 
74咬合紙國械備20250256號Directa   ABFinvids   v?g 8, SE-194 47 Upplands V?sby, Sweden2025-08-15 
75超聲探頭穿刺架國械備20180422號CIVCO   Medical Instruments Co.,Inc.102   FIRST ST.SOUTH Kalona, IA USA 522472025-08-15 
76超聲探頭穿刺架國械備20180216號CIVCO   Medical Instruments Co.,Inc.102   FIRST ST.SOUTH Kalona, IA USA 522472025-08-15 
77超聲探頭穿刺架國械備20181495號CIVCO   Medical Instruments Co., Inc.102   FIRST ST. SOUTH, Kalona, IA USA 52247
   
   		2025-08-15 
78醫(yī)用清洗器國械備20181353號CIVCO   Medical Instruments Co., Inc.102   FIRST ST. SOUTH Kalona, IA USA 522472025-08-15 
79超聲探頭穿刺架國械備20180055號CIVCO   Medical Instruments Co.,Inc.102   FIRST ST.SOUTH Kalona, IA USA 522472025-08-15 
80染色機國械備20160156號Hologic，Inc.250   Campus Drive Marlborough Massachusetts 01752 USA/1750a Costner   Dr.Warrington,PA 18976 USA2025-08-13 
81全自動樣本處理及孵育系統(tǒng)國械備20160837號Hologic,Inc.16990   Goldentop Road, San Diego, CA 92127, United States2025-08-13 
82一次性使用細胞過濾采集器國械備20160620號Hologic,   Inc.250   Campus Drive, Marlborough, Massachusetts, 01752, USA; 4 Navigator Road,   Londonderry, New Hampshire 03053, USA2025-08-13 
83牙用測力計國械備20250255號Kube   Innovation Inc.5524   rue Saint-Patrick, Suite 315 Montréal, Quebec, H4E 1A8, Canada2025-08-13 
84腹透管路夾國械備20151519號Vantive   Health GmbHFoxford   Road, Swinford, CO.Mayo, IRELAND2025-08-13 
85種植體掃描體國械備20180660號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2025-08-12 
86替代體國械備20181382號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2025-08-12 
87口腔科手術(shù)器械國械備20250248號LATNED   DENTALHead,Marala   Road, Machikhokhar Sialkot Pakistan.2025-08-12 
88口外研磨材料國械備20250254號Medifive   Co., Ltd.324,   Korea Industrial Complex, 84, Namdongdong-ro, Namdong-gu, Incheon, Republic   of Korea2025-08-12 
89糞便檢驗預(yù)處理裝置國械備20250253號Apacor   Limited Sapphire   Centre, Fishponds Road, Wokingham Berkshire RG41 2QL United Kingdom.2025-08-12 
90口腔科手術(shù)器械國械備20250252號ENGRAVO   SURGICOAzmat   Lodge,Moh,Hassan Pura,Gulshan Town,Sialkot,Pakistan2025-08-12 
91馬鐙形多功能腿架國械備20160568號Herbert（Thailand）Co.,   Ltd.47   Moo 1  Mitraphap Road, Tambon Samran,   Amphur Muang, Khon Kaen 40000, Thailand2025-08-12 
92夾持器國械備20181256號株式會社システム?ジェーピー靜岡県浜松市東區(qū)下石田町1025番地の12025-08-12 
93馬鐙形多功能腿架國械備20180217號Herbert   （Thailand）Co., Ltd47   Moo 1 Mitraphap Road，Tambon Samran，Amphur Muang，Khon Kaen 40000，Thailand2025-08-12 
94馬鐙形多功能腿架國械備20180218號Herbert   （Thailand）Co.，Ltd.47   Moo 1 Mitraphap Road，Tambon Samran，Amphur Muang，Khon Kaen 40000，Thailand2025-08-12 
95醫(yī)用射線防護用具國械備20210326號WSR   Medical Solutions LTDUnit   E Bridgewater Close, Network 65 Business Park, Hapton,Burnley, BB11 5TE2025-08-12 
96負壓吸引用收集裝置國械備20190592號Medela   AG L?ttichstrasse   4b, 6340 Baar, Switzerland2025-08-11 
97骨傳導(dǎo)植入式聽力系統(tǒng)植入手術(shù)器械包國械備20210449號Elos   Medtech Pinol A/SEngvej   33, G?rl?se 3330, Denmark2025-08-11 
98骨傳導(dǎo)植入式聽力系統(tǒng)植入手術(shù)器械包國械備20210423號Cochlear   Bone Anchored Solutions ABKonstruktionsvagen   14, SE-435 33 Molnlycke, Sweden2025-08-11 
99骨傳導(dǎo)植入式聽力系統(tǒng)植入手術(shù)器械包國械備20190728號Cochlear   Bone Anchored Solutions ABKonstruktionsvagen   14, SE-435 33 Molnlycke, Sweden2025-08-11 
100牽開器國械備20250251號medical   bees GmbHFriedrich-W?hler-Stra?e   13 78576 Emmingen Germany2025-08-11 
101樣本稀釋液國械備20250058號Roche   Diagnostics GmbHNonnenwald   2, 82377 Penzberg, GERMANY2025-08-11 
102醫(yī)用檢查手套國械備20250250號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醫(yī)用壓敏膠帶國械備20250249號????? ???   ??? ??? ??? ???291?? 742025-08-08 
104試模國械備20140363號Smith   & Nephew Orthopaedics AGSchachenallee   29,5001 Aarau, Switzerland; Dammweg 39,5001 Aarau, Switzerland2025-08-08 
105髖關(guān)節(jié)手術(shù)器械國械備20161805號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干式激光成像儀國械備20151260號コニカミノルタ株式會社埼玉県狹山市広瀬臺二丁目2番1號　2-2-1，   Hirosedai，Sayama-shi，Saitama2025-08-07 
107醫(yī)用體位膠墊國械備20140329號????   ???? ????無2025-08-07 
108壓力繃帶國械備20180201號Medi   GmbH & Co.KGMedicusstraβe   1, 95448 Bayreuth, Germany2025-08-07 
109干式激光成像儀國械備20170398號コニカミノルタ株式會社1   Sakura-machi，Hino-shi，Tokyo，Japan；2-2-1，   Hirosedai，Sayama-shi，Saitama，Japan 2025-08-06 
110口腔科手術(shù)器械國械備20250248號LATNED   DENTALHead,Marala   Road, Machikhokhar Sialkot Pakistan.2025-08-05 
111醫(yī)用外固定支具國械備20170130號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彈性繃帶國械備20171074號CIZETA   MEDICALI S.P.A.Via   IV Novembre,46-20012 CUGGIONO(MI)-ITALY2025-08-04 
113口腔科器械國械備20240396號A.Schweickhardt   GmbH＆Co.KGTuttlinger   Straβe 12 78606 Seitingen-Oberflacht Germany2025-08-04 
114牙科骨磨國械備20230091號A.Schweickhardt   GmbH & Co.KGTuttlinger   Stra?e 12 78606 Seitingen/ Tuttlingen Germany2025-08-04 
115口腔科器械國械備20191336號A.Schweickhardt   GmbH＆Co.KGTuttlinger   Stra?e 12 78606 Seitingen / Tuttlingen Germany2025-08-04 
116骨鉸刀國械備20250247號Gebr.   Brasseler GmbH & Co. KGTrophagener   Weg 25 32657 Lemgo Germany2025-08-04 
117自動制片機國械備20151734號Hologic，Inc.445   Simarano Drive, Marlborough, MA 01752 USA2025-08-04 
118清洗液國械備20191034號Hologic,   Inc.10210   Genetic Center Drive, San Diego, CA 92121 UNITED STATES2025-08-04 
119半月板縫合修復(fù)手術(shù)器械（包）國械備20250246號ConMed   Corporation11311   Concept Boulevard, Largo, FL 33773, USA2025-08-04 
120液基薄層細胞制片機國械備20151732號Hologic,Inc.445   Simarano Drive, Marlborough, MA 01752 USA2025-08-04 
121磷酸鹽緩沖液國械備20250245號Miltenyi   Biotec B.V. & Co. KG Robert-Koch-Strasse   1, 17166 Teterow, GERMANY2025-08-01 
122手術(shù)頭架國械備20170083號Herbert（Thailand）Co.,   Ltd.47   Moo 1  Mitraphap Road, Tambon Samran,   Amphur Muang, Khon Kaen 40000, Thailand2025-08-12 

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