Umedwings

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Frequently Asked Questions

What's the deadline for MDR?

2021/5/26 No new MDD CE certificate;

2024/5/26 All MDD CE certificate expired;

2025/5/26 All products under MDD certificate can not sell.

What is SRN?

Single Registration Number,  there are 3 roles manufacturer, an authorized representative, importer need to register SRN number.

What is UDI & Basic UDI?

UDI

UDI-DI device identifier, a fixed code specific to a version or model of a device. 

UDI-PI  production identifier , a variable code related to production data of the device, such as lot/batch number, expiry date, manufacturing date, etc. You mainly put UDI on your products label.


Basic UDI-DI  

intended to group devices with the same intended purpose, risk class, essential design and manufacturing characteristics. You main use it in the Declaration of Conformity.


Netherlands Headquarter:  Treubstraat 1, 2288EG, Rijswijk, The Netherlands .  www.umedwings.eu 

 UK :  291 Brighton Road, South Croydon,  United Kingdom, CR2 6EQ  www.umedwings.uk

USA:  1840 Pickwick Ave Glenview  Illinois 60026  UNITED STATES    www.umedwings.us 

China: 502 Building C, Gold Power Industry Park,Pingshan, Shenzhen,P.R. China 518118  www.umedwings.cn

Email: ar@umedwings.eu Copyright © 2022Umedwings - ISO13485 Certified Company

EU Representative |  MDR/IVDR importer | EU Logistic Center


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