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2025年5月進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息
發(fā)布日期:2025-06-19 17:41瀏覽次數(shù):51次
來自國家藥監(jiān)局近日披露的數(shù)據(jù)，2025年5月，國家藥監(jiān)局批準(zhǔn)液基薄層細(xì)胞制片染色系統(tǒng)、組織鉗、包埋機(jī)、自動切片機(jī)、染色機(jī)、冷凍切片機(jī)、手搖切片機(jī)、耳鼻喉科手術(shù)器械、組織脫水機(jī)、細(xì)胞保存液、超聲潔牙機(jī)工作尖、牙刮匙、種植體清潔用螺絲等158個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息，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5月，國家藥監(jiān)局批準(zhǔn)液基薄層細(xì)胞制片染色系統(tǒng)、組織鉗、包埋機(jī)、自動切片機(jī)、染色機(jī)、冷凍切片機(jī)、手搖切片機(jī)、耳鼻喉科手術(shù)器械、組織脫水機(jī)、細(xì)胞保存液、超聲潔牙機(jī)工作尖、牙刮匙、種植體清潔用螺絲等158個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息，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5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)品名稱醫(yī)療器械產(chǎn)品備案號備案人名稱原文生產(chǎn)地址原文備案日期
腹部造口彈性繃帶國械備20250150號Tytex   A/SChemlonská   1,06601 Humenné, Slovakia2025-05-30 
喉鏡國械備20250149號HILBRO   INTERNATIONAL (PVT) LTD.12   KM Daska Road, P.O. Box 250, Sialkot - Pakistan,2025-05-30 
醫(yī)用檢查手套國械備20250148號Supermax   Glove Manufacturing Sdn. Bhd.Lot   42, Putra Industrial Park, Bukit Rahman Putra, 40160 Sungai Buloh, Selangor   Darul Ehsan, Malaysia2025-05-30 
膝關(guān)節(jié)固定器國械備20170278號?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2025-05-30 
呼吸訓(xùn)練器國械備20160866號 LEVENTON S.A.U.BP   245 Z.I. Hammam-Zriba, 1152 Zaghouan, Tunisie2025-05-29 
放射治療患者用固定裝置國械備20151105號MACROMEDICS   B.V.Kouwe   Hoek 18,2741 PX-Waddinxveen(The Netherlands)2025-05-29 
牙科種植掃描體國械備20210008號C-Tech   Implant S.r.l.Via   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2025-05-28 
造口袋國械備20210159號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2025-05-28 
造口底盤國械備20200110號ConvaTec   Inc.Carretera   Sanchez, Km. 18.5, Parque Industrial Itabo S.A. Buildings 23, 29, 30 Haina,   San Cristobal, 91000 Dominican Republic.2025-05-28 
造口袋國械備20190016號アルケア株式會社千葉県千葉市花見川區(qū)千種町36-22025-05-28 
彈性醫(yī)用膠布國械備20140098號ァルケァ株式會社289-4   Chigusa-Cho, Hanamigawa-Ku, Chiba-Shi, Chiba, Japan2025-05-28 
人體定位墊國械備20240119號ァルケァ株式會社千葉県千葉市花見川區(qū)千種町   289-42025-05-28 
造口袋國械備20140361號ァルケァ株式會社289-4   CHIGUSA-CHO, HANAMIGAWA-KU, CHIBA-SHI, CHIBA, JAPAN2025-05-28 
造口袋國械備20190015號アルケア株式會社千葉県千葉市花見川區(qū)千種町36-22025-05-28 
造口皮膚保護(hù)劑國械備20190017號アルケア株式會社千葉県千葉市花見川區(qū)千種町36-22025-05-28 
造口灌洗器國械備20210041號アルケア株式會社千葉県千葉市花見川區(qū)千種町289-42025-05-28 
上頜竇咬骨鉗國械備20150127號Max   Hauser Süeddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany
   
   		2025-05-27 
吸引管國械備20170478號Max   Hauser Süeddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-05-27 
口腔科手術(shù)器械國械備20220329號LEGEND   GROUPAeminabad   Road,Village Adam Daraz,Sialkot-Pakistan2025-05-27 
口腔科手術(shù)器械國械備20220516號SMILE   SURGICAL INSTRUMENTSMohalla   Mollma Machi Khokhar,Head Marala Road,Sialkot-51310-Pakistan  2025-05-27 
口腔治療器具國械備20250147號MEDIXDENT   INTERNATIONAL47-A   Ground Floor, Pak Block, Allama Iqbal Town Lahore - Pakistan2025-05-27 
基礎(chǔ)外科手術(shù)器械國械備20250146號HEXAMED（PRIVATE）LIMITEDBarlas   Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan.2025-05-27 
口腔治療器具國械備20250145號Surtex   Instruments Ltd.Kingspark   Business Centre, Unit 202, 152-178 Kingston Road, New Malden, KT3 3ST Great   Britain.2025-05-27 
骨科手術(shù)器械國械備20250144號HEXAMED（PRIVATE）LIMITEDBarlas   Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan.2025-05-27 
羊水細(xì)胞培養(yǎng)基 Chang Medium C  國械備20160924號 Irvine   Scientific, LLC2511   Daimler Street Santa Ana, CA 92705 USA2025-05-27 
羊水細(xì)胞培養(yǎng)基國械備20151953號Irvine   Scientific, LLC2511   Daimler ST Santa Ana, CA USA 927052025-05-27 
羊水細(xì)胞培養(yǎng)基 Chang Medium C 國械備20190795號 Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
外周血淋巴細(xì)胞培養(yǎng)基國械備20160843號Irvine   Scientific, LLC2511   Daimler Street Santa Ana, CA 92705 USA2025-05-27 
羊水細(xì)胞培養(yǎng)基 Chang Medium? D國械備20160844號Irvine   Scientific, LLC2511   Daimler Street Santa Ana, CA 92705 USA2025-05-27 
骨髓細(xì)胞培養(yǎng)基 Chang Medium BMC國械備20190657號Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
羊水細(xì)胞培養(yǎng)基 Chang Medium B國械備20190799號Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
羊水細(xì)胞培養(yǎng)基 Chang Medium D國械備20190656號Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
羊水細(xì)胞培養(yǎng)基 Chang Medium? In Situ國械備20160859號Irvine   Scientific, LLC2511   Daimler Street Santa Ana, CA 92705 USA2025-05-27 
骨髓細(xì)胞培養(yǎng)基 Chang Marrow國械備20190796號Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
羊水細(xì)胞培養(yǎng)基 Chang Medium C 國械備20190798號Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
血細(xì)胞分析用溶血劑國械備20150018號HORIBA   ABX SASParc   Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France2025-05-27 
樣本稀釋液 Alinity c ICT Sample Diluent國械備20181002號Abbott   GmbH8365   Valley Pike Middletown, VA 22645 USA2025-05-26 
呼吸訓(xùn)練器 國械備20150135號Leventon   S.A.U.BP   245 Z.I. Hammam-Zriba, 1152 Zaghouan, Tunisie2025-05-26 
輪轉(zhuǎn)式切片機(jī)國械備20150178號MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf
   
   		2025-05-23 
自動組織脫水機(jī)國械備20140170號MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf
   
   		2025-05-23 
冷凍切片機(jī) 國械備20150255號MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf2025-05-23 
組織染色機(jī)國械備20140169號MEDITE   Medical GmbH國械備201401692025-05-23 
輪轉(zhuǎn)式切片機(jī)國械備20140038號MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf2025-05-23 
牙科種植器械工具國械備20240264號8dent   Inc.20-13,   Seogimhaesandan-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea2025-05-23 
口腔燈國械備20200564號Takara   Belmont Corporation2-6-59,   Kitatsumori, Nishinari-ku, Osaka, 557-0061, Japan2025-05-22 
細(xì)胞周期蛋白D1抗體試劑（免疫組織化學(xué)）國械備20181772號Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States2025-05-22 
牙科拋光條國械備20161137號株式會社ジーシーデンタルプロダクツ愛知県春日井市鳥居松町2丁目285番地2025-05-22 
TdT 抗體試劑（免疫組織化學(xué)）國械備20190518號Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States2025-05-22 
Myo D1抗體試劑（免疫組織化學(xué)）國械備20190503號Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States2025-05-22 
GCDFP-15抗體試劑（免疫組織化學(xué)）國械備20190475號Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, CA 93013 United States2025-05-22 
CD5抗體試劑（免疫組織化學(xué)）國械備20181775號Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States2025-05-22 
清洗液國械備20190536號Agilent   Technologies, Inc.Produktionsvej   42, DK-2600 Glostrup, Denmark；1170 Mark Ave, Carpinteria, CA 93013 United   States2025-05-22 
造口皮膚保護(hù)劑國械備20191410號Coloplast   A/Sul.Szczakowska   35, 43-600 Jaworzno, Poland2025-05-22 
造口袋國械備20200640號Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary 2025-05-22 
造口袋國械備20190948號Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2025-05-22 
骨鉸刀國械備20170662號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
快裝手柄國械備20170661號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
試模國械備20170659號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨科用螺絲刀國械備20170660號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
打孔器國械備20170655號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
導(dǎo)鉆國械備20170658號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
拔出器國械備20170657號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨測量器國械備20170653號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨銼國械備20170656號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨科定位片國械備20170654號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
打入器國械備20170652號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
固定針國械備20170651號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨鉆國械備20171231號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
試模國械備20171230號Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
耳鏡國械備20190791號Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2025-05-22 
耳鏡國械備20210416號Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2025-05-22 
雙翼陰道擴(kuò)張器國械備20160356號Rudolf   Riester GmbHSmall   Industrial Estate, Sialkot-Pakistan2025-05-22 
病理石蠟包埋機(jī)國械備20140213號MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf
   
   		2025-05-22 
染色機(jī)國械備20151321號 Leica Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-05-22 
全自動染色封片一體機(jī)國械備20230396號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19, 69226 Nussloch, Germany2025-05-22 
染色機(jī) 國械備20151853號 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-05-22 
封片機(jī)國械備20220343號Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-05-22 
打磨拋光器具國械備20250143號Hopf,   Ringleb & Co. GmbH & Cie.Gardeschützenweg   82 12203 Berlin Germany2025-05-22 
醫(yī)用激光膠片國械備20171024號コニカミノルタ株式會社8124   Pacific Avenue White City，Oregen USA 97503；日本埼玉県久喜市菖蒲町三箇6201-62025-05-21 
聽覺檢查音叉國械備20170546號Rudolf   Riester GmbHBruckstra?e   31, 72417 Jungingen, Germany2025-05-21 
醫(yī)用檢查燈國械備20190355號Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2025-05-21 
 二用聽診器 國械備20150317號Rudolf   Riester GmbHBruckstraβe   31 72417 Jungingen, Germany2025-05-21 
手術(shù)放大鏡國械備20151134號Rudolf   Riester GmbHClewer   Hill Road, Windsor, Berkshire SL4 4AA, United Kingdom2025-05-21 

由于文章篇幅限制，本文并未列出全部158個進(jìn)口第一類醫(yī)療器械產(chǎn)品備案信息，如有進(jìn)口第一類醫(yī)療器械產(chǎn)品備案代理服務(wù)需求，歡迎您隨時方便與杭州證標(biāo)客醫(yī)藥技術(shù)咨詢有限公司聯(lián)絡(luò)，聯(lián)系人：呂工，電話：18058734169，微信同。

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