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當(dāng)前位置：網(wǎng)站首頁(yè)>新聞動(dòng)態(tài) >國(guó)家局2025年1月批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案163項(xiàng)
國(guó)家局2025年1月批準(zhǔn)進(jìn)口第一類醫(yī)療器械產(chǎn)品備案163項(xiàng)
發(fā)布日期:2025-02-10 00:00瀏覽次數(shù):240次
?來(lái)自國(guó)家藥監(jiān)局2025年2月10日披露的數(shù)據(jù)，2025年1月，國(guó)家藥監(jiān)局批準(zhǔn)口腔科手術(shù)器械、防散射濾線柵、種植體螺絲起、緩沖液、糞便檢驗(yàn)預(yù)處理裝置、耳用定位模板、耳鼻喉科用測(cè)量器、海綿鉗等進(jìn)口第一類醫(yī)療器械產(chǎn)品備案163項(xiàng)，一起來(lái)看具體內(nèi)容。

來(lái)自國(guó)家藥監(jiān)局2025年2月10日披露的數(shù)據(jù)，2025年1月，國(guó)家藥監(jiān)局批準(zhǔn)口腔科手術(shù)器械、防散射濾線柵、種植體螺絲起、緩沖液、糞便檢驗(yàn)預(yù)處理裝置、耳用定位模板、耳鼻喉科用測(cè)量器、海綿鉗等進(jìn)口第一類醫(yī)療器械產(chǎn)品備案163項(xiàng)，一起來(lái)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1月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息（部分產(chǎn)品）


產(chǎn)品名稱備案號(hào)備案人名稱原文生產(chǎn)地址原文備案日期
口腔科手術(shù)器械國(guó)械備20250028號(hào)ISMA   ISHAQ INTERNATIONALBuilding   No.25,Rubi Villas,Kashmir Road,Pakka Garrah,Sialkot Sialkot2025-01-27 
防散射濾線柵國(guó)械備20250027號(hào)SOYEE   PRODUCT INC23,Sunhwan-ro   198 beon-gil,Jungwon-gu,Seongnam-si,Gyeonggi-do,Korea2025-01-27 
種植體螺絲起國(guó)械備20190466號(hào)OSSTEM   ORTHODONTICS Inc.(Ojeon-dong,   Byeoksantechnopia), A-1204, 13 Ojeongongeop-gil, Uiwang-si, Gyeonggi-do,   Korea2025-01-27 
緩沖液國(guó)械備20170685號(hào)Eiken   Chemical Co., Ltd.1381-3   Shimoishigami, Otawara-shi, Tochigi    324-0036，Japan2025-01-26 
糞便檢驗(yàn)預(yù)處理裝置國(guó)械備20151619號(hào)栄研化學(xué)株式會(huì)社靜岡県榛原郡吉田町神戸35852025-01-26 
樣本稀釋液國(guó)械備20160165號(hào)Siemens   Healthcare Diagnostics Inc.333   Coney Street, East Walpole, Massachusetts 02032, USA2025-01-26 
耳用定位模板國(guó)械備20191428號(hào)MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A 6020 Innsbruck Austria2025-01-26 
耳鼻喉科用測(cè)量器國(guó)械備20210025號(hào)MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A，6020 Innsbruck，AUSTRIA2025-01-26 
耳用定位模板國(guó)械備20190574號(hào)MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A，6020 Innsbruck Austria2025-01-26 
器械鉗國(guó)械備20190573號(hào)MED-EL   Elektromedizinische Ger?te GmbHFürstenweg   77A，6020 Innsbruck Austria2025-01-26 
核酸提取或純化試劑  i-densy Pack   UNIVERSAL國(guó)械備20190711號(hào)株式會(huì)社　アークレイ　ファクトリー 滋賀県甲賀市甲南町柑子1480番地2025-01-26 
糖化血紅蛋白溶血?jiǎng)?/td>國(guó)械備20150532號(hào)株式會(huì)社　アークレイ　ファクトリー滋賀県甲賀市甲南町柑子1480番地　1480   Koji, Konan-cho, Koka-shi, Shiga 520-3306, JAPAN2025-01-26 
糖化血紅蛋白溶血?jiǎng)?/td>國(guó)械備20220533號(hào)株式會(huì)社　アークレイ　ファクトリー山口県周南市開(kāi)成町4560番地2025-01-26 
種植工具包國(guó)械備20240152號(hào)Adam’s   Aid Corporation14-A,   Small Industrial Estate, Sialkot-51310 Pakistan2025-01-26 
拉鉤國(guó)械備20160310號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany
   
   		2025-01-26 
醫(yī)用鑷國(guó)械備20150930號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany
   
   		2025-01-26 
顯微持針鉗國(guó)械備20170002號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-01-26 
顯微剪國(guó)械備20151125號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-01-26 
組織鉗國(guó)械備20170414號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-01-26 
止血鉗國(guó)械備20150031號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-01-26 
組織擴(kuò)張器或乳房假體試模國(guó)械備20170169號(hào)AllerganGlobal   Park Free Zone, La Aurora de Heredia 900 Parkway CRI2025-01-26 
糖化血紅蛋白溶血?jiǎng)?/td>國(guó)械備20250026號(hào)Roche   Diagnostics GmbHSandhofer   Strasse 116, 68305 Mannheim, Germany2025-01-24 
海綿鉗國(guó)械備20170412號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-01-23 
腹腔用拉鉤裝置器國(guó)械備20160311號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-01-23 
持針鉗國(guó)械備20150315號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-01-23 
EZH2抗體試劑（免疫組織化學(xué)）國(guó)械備20190332號(hào)Leica   Biosystems Newcastle Ltd.Balliol   Business Park West, Benton Lane, Newcastle upon Tyne, NE12 8EW, United   Kingdom.2025-01-23 
骨用牽開(kāi)器國(guó)械備20150071號(hào)Max   Hauser Süddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany
   
   		2025-01-23 
醫(yī)用成像體外定位標(biāo)記貼國(guó)械備20250025號(hào)COMPASS   INTERNATIONAL1815   14TH ST. NW, SUITE A, Rochester, MN US 559012025-01-23 
全自動(dòng)紅細(xì)胞沉降率測(cè)定儀國(guó)械備20220075號(hào)DIESSE   Diagnostica Senese S.p.A.Strada   dei Laghi 39, 53035 Monteriggioni (SI) Italy2025-01-23 
面中部和顱面骨創(chuàng)傷治療和重建手術(shù)工具包國(guó)械備20160728號(hào)維綱生物科技股份有限公司新竹縣湖口鄉(xiāng)鳳山村光復(fù)路58-1號(hào)3樓2025-01-23 
種植工具包國(guó)械備20230006號(hào)SOBYTEK   INSTRUMENTS CO.Roras   Road, Muzaffar Pur, Sialkot 51310 - Pakistan2025-01-23 
CD62L檢測(cè)試劑(流式細(xì)胞儀法)國(guó)械備20250020號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212025-01-23 
CD45RO抗體試劑國(guó)械備20250022號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212025-01-23 
CD30抗體試劑（流式細(xì)胞儀法）國(guó)械備20250023號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212025-01-23 
CD30抗體試劑（流式細(xì)胞儀法）國(guó)械備20250024號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212025-01-23 
CD62L檢測(cè)試劑(流式細(xì)胞儀法)國(guó)械備20250021號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212025-01-23 
CD81抗體試劑國(guó)械備20250019號(hào)BioLegend,Inc.8999   BioLegend Way Third Floor GMP Suite, San Diego, CA USA 921212025-01-23 
光固化模型樹(shù)脂國(guó)械備20160472號(hào)Ultradent   Products, Inc.505   West 10200 South Utah 84095 / South Jordan USA2025-01-23 
CD10抗體試劑（免疫組織化學(xué)）國(guó)械備20220177號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42, Glostrup DK-2600, Denmark2025-01-21 
脊柱手術(shù)工具 國(guó)械備20161991號(hào)SPINENDOS   GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2025-01-21 
p40抗體試劑（免疫組織化學(xué)）國(guó)械備20220172號(hào)Agilent   Technologies Singapore (International) Pte. Ltd.Produktionsvej   42, Glostrup DK-2600 , Denmark2025-01-21 
低離子強(qiáng)度鹽溶液 國(guó)械備20151461號(hào)Immucor,   Inc.3130   Gateway Drive, Norcross, Georgia 30071,USA2025-01-21 
種植輔助材料國(guó)械備20210106號(hào)CSM   Implant35,   Seongjusaneopdanji-ro, Seongju-eup, Seongju-gun, Gyeongsangbuk-do,40031, Rep.   of KOREA2025-01-21 
顯微持針鑷國(guó)械備20170855號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2025-01-20 
醫(yī)用檢查音叉國(guó)械備20171244號(hào)RZ   Medizintechnik GmnHUnter   Hasslen 20 78532 Tuttlingen Germany2025-01-20 
手外科固定復(fù)位鑷國(guó)械備20171154號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2025-01-20 
顯微剪國(guó)械備20170856號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2025-01-20 
顯微止血夾國(guó)械備20170848號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany2025-01-20 
顯微鑷國(guó)械備20170009號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
吸引管國(guó)械備20160141號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
口腔開(kāi)口器國(guó)械備20160034號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
鉤針國(guó)械備20160033號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
骨銼國(guó)械備20152119號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
剝離器國(guó)械備20152132號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
骨鑿 國(guó)械備20152131號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
鼻窺器國(guó)械備20152118號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
刮匙國(guó)械備20151685號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
醫(yī)用剪國(guó)械備20151641號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
止血鉗 國(guó)械備20151642號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2025-01-20 
組織鉗國(guó)械備20150692號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2025-01-20 
 支撐喉鏡國(guó)械備20180222號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 78532 Tuttlingen Germany 2025-01-20 
骨錘國(guó)械備20160030號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
探針國(guó)械備20160028號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
手術(shù)刀國(guó)械備20152117號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
外科牽開(kāi)器國(guó)械備20152120號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20, D-78532 Tuttlingen,Germany2025-01-20 
持針鉗國(guó)械備20150693號(hào)RZ   Medizintechnik GmbHUnter   Hasslen 20 D-78532 Tuttlingen2025-01-20 

文章篇幅限制，本文并未列出全部進(jìn)口第一類醫(yī)療器械備案產(chǎn)品，如有進(jìn)口第一類醫(yī)療器械產(chǎn)品備案咨詢服務(wù)需求，歡迎您隨時(shí)方便與杭州證標(biāo)客醫(yī)藥技術(shù)咨詢有限公司聯(lián)絡(luò)，聯(lián)系人：葉工，電話：18058734169，微信同。


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