Congratulation! Unimed Obtains MDR Notification Certificate

We are pleased to announce that Unimed Medical Supplies Inc. successfully passed review of the EU authorized representative, and obtained MDR Notification Certificate , REF. NO.:LCA 1041-2021

Unimed Class I devices are fulfilling the applicable requirements of the MDR compliance and have the qualification to continue to place these devices on the market of European Union and EEA territory after the full implementation of the MDR on May 26, 2021. (Please see attached list for Unimed 14 Class I devices )

For Unimed Class IIa and Class IIb medical devices, until May 2024, products which

have been certified under MDD can under certain conditions still be placed on the

market after the MDR fully applies, as long as the EC certificate are valid.

Accordingly, Unimed will continue to place MDD certified medical devices no the

market during this period, until the certificate expires (June 8, 2023).

At the same time,we are carrying out the MDR certification of Class II devices, including

SpO2 Sensors and temperature probes.

We are looking forward to further cooperation with you.