Public EUDAMED Search

EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

Last updated

14.10.2026 20:26

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3 device results listed.

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IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005009
Basic UDI-DI: 0857167005RM0030017M
Reference: RM003001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Roche Diagnostics GmbH
Last updated: 01.10.2026 18:09

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005382
Basic UDI-DI: 085716700510107545001KP
Reference: 10107545001
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Netherlands
Authorised representative: Roche Diagnostics GmbH
Last updated: 01.10.2026 18:09

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: GenMark Diagnostics
Manufacturer SRN: US-MF-000010772
UDI-DI: 00857167005399
Basic UDI-DI: 085716700510246944001PN
Reference: 10246944001
EMDN: W0105070304
EMDN description: INFLUENZA & PARA INFLUENZA / RESPIRATORY SYNCYTIAL VIRUS (RSV) / SARS-COV - MULTIPLEX NA REAGENTS
First on market country: Netherlands
Authorised representative: Roche Diagnostics GmbH
Last updated: 01.10.2026 18:09