医疗器械法规、注册、临床、体系认证、信息系统一站式服务
24×7服务热线：0571-86198618 简体中文 ENGLISH
新闻动态
医疗器械注册
医疗器械CE认证
医疗器械临床试验
医疗器械经营许可
联系我们

公众号二维码.jpg

 联系电话：0571-86198618手机: 18058734169 (微信同)手机:18868735317（微信同)周一至周日 8:00~22:00
在线客服周一至周日 8:00~22:00

QQ在线客服

 

当前位置：网站首页>新闻动态 >2025年5月进口第一类医疗器械产品备案信息
2025年5月进口第一类医疗器械产品备案信息
发布日期:2025-06-19 17:41浏览次数:122次
来自国家药监局近日披露的数据，2025年5月，国家药监局批准液基薄层细胞制片染色系统、组织钳、包埋机、自动切片机、染色机、冷冻切片机、手摇切片机、耳鼻喉科手术器械、组织脱水机、细胞保存液、超声洁牙机工作尖、牙刮匙、种植体清洁用螺丝等158个进口第一类医疗器械产品备案信息，一起来看具体内容。

来自国家药监局近日披露的数据，2025年5月，国家药监局批准液基薄层细胞制片染色系统、组织钳、包埋机、自动切片机、染色机、冷冻切片机、手摇切片机、耳鼻喉科手术器械、组织脱水机、细胞保存液、超声洁牙机工作尖、牙刮匙、种植体清洁用螺丝等158个进口第一类医疗器械产品备案信息，一起来看具体内容。

进口第一类医疗器械产品备案.jpg

2025年5月进口第一类医疗器械产品备案信息（部分产品）

产品名称医疗器械产品备案号备案人名称原文生产地址原文备案日期
腹部造口弹性绷带国械备20250150号Tytex   A/SChemlonská   1,06601 Humenné, Slovakia2025-05-30 
喉镜国械备20250149号HILBRO   INTERNATIONAL (PVT) LTD.12   KM Daska Road, P.O. Box 250, Sialkot - Pakistan,2025-05-30 
医用检查手套国械备20250148号Supermax   Glove Manufacturing Sdn. Bhd.Lot   42, Putra Industrial Park, Bukit Rahman Putra, 40160 Sungai Buloh, Selangor   Darul Ehsan, Malaysia2025-05-30 
膝关节固定器国械备20170278号?ssur   hf.Grjotháls   1-5 Reykjavik 110 Iceland2025-05-30 
呼吸训练器国械备20160866号 LEVENTON S.A.U.BP   245 Z.I. Hammam-Zriba, 1152 Zaghouan, Tunisie2025-05-29 
放射治疗患者用固定装置国械备20151105号MACROMEDICS   B.V.Kouwe   Hoek 18,2741 PX-Waddinxveen(The Netherlands)2025-05-29 
牙科种植扫描体国械备20210008号C-Tech   Implant S.r.l.Via   Ravenna 382, 40018 San Pietro in Casale(BO), ITALY2025-05-28 
造口袋国械备20210159号ConvaTec   Inc.Carretera   Sanchez, Km. 18.5 Parque Industrial Itabo, S.A. Buildings 23, 29, 30 Haina,   San Cristobal 91000 Dominican Republic2025-05-28 
造口底盘国械备20200110号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 
造口袋国械备20190016号アルケア株式会社千葉県千葉市花見川区千種町36-22025-05-28 
弹性医用胶布国械备20140098号ァルケァ株式会社289-4   Chigusa-Cho, Hanamigawa-Ku, Chiba-Shi, Chiba, Japan2025-05-28 
人体定位垫国械备20240119号ァルケァ株式会社千葉県千葉市花見川区千種町   289-42025-05-28 
造口袋国械备20140361号ァルケァ株式会社289-4   CHIGUSA-CHO, HANAMIGAWA-KU, CHIBA-SHI, CHIBA, JAPAN2025-05-28 
造口袋国械备20190015号アルケア株式会社千葉県千葉市花見川区千種町36-22025-05-28 
造口皮肤保护剂国械备20190017号アルケア株式会社千葉県千葉市花見川区千種町36-22025-05-28 
造口灌洗器国械备20210041号アルケア株式会社千葉県千葉市花見川区千種町289-42025-05-28 
上颌窦咬骨钳国械备20150127号Max   Hauser Süeddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany
   
   		2025-05-27 
吸引管国械备20170478号Max   Hauser Süeddeutsche Chirurgiemechanik GmbHF?hrenstra?e   33，78532 Tuttlingen Germany2025-05-27 
口腔科手术器械国械备20220329号LEGEND   GROUPAeminabad   Road,Village Adam Daraz,Sialkot-Pakistan2025-05-27 
口腔科手术器械国械备20220516号SMILE   SURGICAL INSTRUMENTSMohalla   Mollma Machi Khokhar,Head Marala Road,Sialkot-51310-Pakistan  2025-05-27 
口腔治疗器具国械备20250147号MEDIXDENT   INTERNATIONAL47-A   Ground Floor, Pak Block, Allama Iqbal Town Lahore - Pakistan2025-05-27 
基础外科手术器械国械备20250146号HEXAMED（PRIVATE）LIMITEDBarlas   Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan.2025-05-27 
口腔治疗器具国械备20250145号Surtex   Instruments Ltd.Kingspark   Business Centre, Unit 202, 152-178 Kingston Road, New Malden, KT3 3ST Great   Britain.2025-05-27 
骨科手术器械国械备20250144号HEXAMED（PRIVATE）LIMITEDBarlas   Street, Opposite Hotel The Jeevens, Kashmir Road,Sialkot-51310, Pakistan.2025-05-27 
羊水细胞培养基 Chang Medium C  国械备20160924号 Irvine   Scientific, LLC2511   Daimler Street Santa Ana, CA 92705 USA2025-05-27 
羊水细胞培养基国械备20151953号Irvine   Scientific, LLC2511   Daimler ST Santa Ana, CA USA 927052025-05-27 
羊水细胞培养基 Chang Medium C 国械备20190795号 Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
外周血淋巴细胞培养基国械备20160843号Irvine   Scientific, LLC2511   Daimler Street Santa Ana, CA 92705 USA2025-05-27 
羊水细胞培养基 Chang Medium? D国械备20160844号Irvine   Scientific, LLC2511   Daimler Street Santa Ana, CA 92705 USA2025-05-27 
骨髓细胞培养基 Chang Medium BMC国械备20190657号Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
羊水细胞培养基 Chang Medium B国械备20190799号Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
羊水细胞培养基 Chang Medium D国械备20190656号Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
羊水细胞培养基 Chang Medium? In Situ国械备20160859号Irvine   Scientific, LLC2511   Daimler Street Santa Ana, CA 92705 USA2025-05-27 
骨髓细胞培养基 Chang Marrow国械备20190796号Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
羊水细胞培养基 Chang Medium C 国械备20190798号Irvine   Scientific, LLC2511   Daimler Street, Santa Ana, CA 92705, USA2025-05-27 
血细胞分析用溶血剂国械备20150018号HORIBA   ABX SASParc   Euromédecine-rue du Caducée, BP 7290 34184 MONTPELLIER Cedex 4, France2025-05-27 
样本稀释液 Alinity c ICT Sample Diluent国械备20181002号Abbott   GmbH8365   Valley Pike Middletown, VA 22645 USA2025-05-26 
呼吸训练器 国械备20150135号Leventon   S.A.U.BP   245 Z.I. Hammam-Zriba, 1152 Zaghouan, Tunisie2025-05-26 
轮转式切片机国械备20150178号MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf
   
   		2025-05-23 
自动组织脱水机国械备20140170号MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf
   
   		2025-05-23 
冷冻切片机 国械备20150255号MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf2025-05-23 
组织染色机国械备20140169号MEDITE   Medical GmbH国械备201401692025-05-23 
轮转式切片机国械备20140038号MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf2025-05-23 
牙科种植器械工具国械备20240264号8dent   Inc.20-13,   Seogimhaesandan-ro, Gimhae-si, Gyeongsangnam-do, Republic of Korea2025-05-23 
口腔灯国械备20200564号Takara   Belmont Corporation2-6-59,   Kitatsumori, Nishinari-ku, Osaka, 557-0061, Japan2025-05-22 
细胞周期蛋白D1抗体试剂（免疫组织化学）国械备20181772号Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States2025-05-22 
牙科抛光条国械备20161137号株式会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 抗体试剂（免疫组织化学）国械备20190518号Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States2025-05-22 
Myo D1抗体试剂（免疫组织化学）国械备20190503号Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States2025-05-22 
GCDFP-15抗体试剂（免疫组织化学）国械备20190475号Agilent   Technologies, Inc.1170   Mark Ave. Carpinteria, CA 93013 United States2025-05-22 
CD5抗体试剂（免疫组织化学）国械备20181775号Agilent   Technologies, Inc.1170   Mark Ave, Carpinteria, CA 93013 United States2025-05-22 
清洗液国械备20190536号Agilent   Technologies, Inc.Produktionsvej   42, DK-2600 Glostrup, Denmark；1170 Mark Ave, Carpinteria, CA 93013 United   States2025-05-22 
造口皮肤保护剂国械备20191410号Coloplast   A/Sul.Szczakowska   35, 43-600 Jaworzno, Poland2025-05-22 
造口袋国械备20200640号Coloplast   A/SColoplast   Hungary KFT, Kerék utca 4, 2800 Tatabánya, Hungary 2025-05-22 
造口袋国械备20190948号Coloplast   A/SBúzavirág   út 15, 2800 Tatabánya, Hungary2025-05-22 
骨铰刀国械备20170662号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
快装手柄国械备20170661号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
试模国械备20170659号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨科用螺丝刀国械备20170660号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
打孔器国械备20170655号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
导钻国械备20170658号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
拔出器国械备20170657号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨测量器国械备20170653号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨锉国械备20170656号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨科定位片国械备20170654号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
打入器国械备20170652号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
固定针国械备20170651号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
骨钻国械备20171231号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
试模国械备20171230号Ortho   Development Corporation12187   S. Business Park Drive, Draper, Utah, 84020-8663, USA2025-05-22 
耳镜国械备20190791号Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2025-05-22 
耳镜国械备20210416号Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2025-05-22 
双翼阴道扩张器国械备20160356号Rudolf   Riester GmbHSmall   Industrial Estate, Sialkot-Pakistan2025-05-22 
病理石蜡包埋机国械备20140213号MEDITE   Medical GmbHWollenweberstrasse   12, 31303 Burgdorf
   
   		2025-05-22 
染色机国械备20151321号 Leica Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-05-22 
全自动染色封片一体机国械备20230396号Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19, 69226 Nussloch, Germany2025-05-22 
染色机 国械备20151853号 Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-05-22 
封片机国械备20220343号Leica   Biosystems Nussloch GmbHHeidelberger   Strasse 17-19 69226 Nussloch Germany2025-05-22 
打磨抛光器具国械备20250143号Hopf,   Ringleb & Co. GmbH & Cie.Gardeschützenweg   82 12203 Berlin Germany2025-05-22 
医用激光胶片国械备20171024号コニカミノルタ株式会社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 
听觉检查音叉国械备20170546号Rudolf   Riester GmbHBruckstra?e   31, 72417 Jungingen, Germany2025-05-21 
医用检查灯国械备20190355号Rudolf   Riester GmbHBruckstraβe   31, 72417 Jungingen, Germany2025-05-21 
 二用听诊器 国械备20150317号Rudolf   Riester GmbHBruckstraβe   31 72417 Jungingen, Germany2025-05-21 
手术放大镜国械备20151134号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个进口第一类医疗器械产品备案信息，如有进口第一类医疗器械产品备案代理服务需求，欢迎您随时方便与杭州证标客医药技术咨询有限公司联络，联系人：吕工，电话：18058734169，微信同。

Copyright © 2018 医疗器械注册技术咨询 浙ICP备18025678号 技术支持：熙和网络