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EUDAMED Device Search

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

Last updated

20.09.2026 13:34

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HGINR-1

IVD self-testing devicesIVDDOn the marketInstrumentSelf testing

Manufacturer: Helixgen (GUANGZHOU) Co., Ltd.
Manufacturer SRN: CN-MF-000034593
UDI-DI: 06953792720141
Basic UDI-DI: B-06953792720141
Reference: HZ-200401
EMDN: W02020602
EMDN description: RAPID TEST HEMOSTASIS INSTRUMENTS
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:38

PT/INR test strip

IVD self-testing devicesIVDDOn the marketKitReagentSelf testingSingle use

Manufacturer: Helixgen (GUANGZHOU) Co., Ltd.
Manufacturer SRN: CN-MF-000034593
UDI-DI: 06953792720134
Basic UDI-DI: B-06953792720134
Reference: HZ-200124
EMDN: W0103020801
EMDN description: PROTHROMBIN TIME RT & POC
First on market country: Poland
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 03.08.2026 21:38