欧洲CE认证医疗器械涉及到一些相关的术语和系统，包括MDR（Medical Device Regulation）、SRN（Single Registration Number）、UDI（Unique Device Identifier）、Eudamed（European Database on Medical Devices）和GS1。1.MDR（Medical Device Regulation）：MDR是欧盟对医疗器械的新法规，于2017年发布，并在2021年5月26日...
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BSI Medical Devices levert kwaliteitsmanagement beoordelingen en CE-certificering voor medische hulpmiddelen wereldwijd, en we kunnen het ook voor u doen.
Wellkang is also a registered UK Responsible Person (UKRP) in the UK MHRA medical device database for the market of Great Britain: England, Wales & Scotland, after 1 Jan 2021, which is no longer part of the EU single market after Brexit. ...
IR182 / Evaluation of the“EUropean DAtabank on MEdical Devices” 2012 其他 EN 下载 IR183 / IVDRdevice Basic UDI-DI & UDI-DI attributes Basic UDI-DI set of data in UDI database 2019 其他 EN 下载 IR184 / Draft Functional specifications for the European Database on Medical Devices (Eudamed...
European Commission's EU medical device databaseEUDAMED Single Registration Number (SRN) XI-AR-000001836 markets of EEA/EU27 & Northern Ireland. registered UK Responsible Person (UKRP) UK MHRA medical device database Great Britain: England, Wales & Scotland ...
要办理血压表在欧洲的MDR(Medical Device Regulation)CE认证,您可以按照以下步骤进行: 确定设备分类:了解血压表在欧洲的设备分类,并确定所属的适用类别。根据设备的风险级别和用途,确定所需的认证路径和技术文件。 准备技术文件:收集和准备需要提交的技术文件,包括设备规格、设计和制造过程、性能测试数据、材料成分、风险...
要办理低温治疗仪在欧洲的MDR(Medical Device Regulation)CE认证,您可以按照以下步骤进行: 确定产品分类:首先,确定低温治疗仪的欧洲医疗器械分类。根据MDR的分类规则,医疗器械被分为不同的类别(I类、IIa类、IIb类、III类),根据风险水平的不同,认证要求和程序也会有所不同。
13 欧盟指南查询和下载https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en 14International Medical Device Regulators Forum国际医疗器械监管机构论坛http://www.imdrf.org/ 15 EU NB 欧盟公告机构https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=notifiedbod...
FDA常用查询网站入口 1.医疗器械数据库 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/medical-device-databases 2.FDA官方指南 https://www.fda.gov/regulatory-infor…