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EUDAMED Device Search

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

Last updated

22.09.2026 20:14

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3 device results listed.

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NAE 2 PLUS

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246221
Basic UDI-DI: 08600102462NucleicAcidVQ
Reference: NAE 2 PLUS
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53

KadieCheck® Pro Max

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246214
Basic UDI-DI: 08600102462PCRL9
Reference: KadieCheck® Pro Max
EMDN: W02050199
EMDN description: NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - OTHER
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53

FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)

IVD Class AIVDR 2017/746On the marketDirect markingInstrumentProfessional testing

Manufacturer: Bifour Biotech Inc.
Manufacturer SRN: US-MF-000034957
UDI-DI: 00860010246207
Basic UDI-DI: 08600102462BBIITRI001AN
Reference: FIAPresto™, FIAPresto™II, FIAPresto™III， FIAVet™, FIAVet™II, FIAVet™III (Bifour/Vetfor)
EMDN: W0201020192
EMDN description: AUTOMATED IMMUNOCHEMISTRY ANALYSERS - IVD MEDICAL DEVICE SOFTWARE
First on market country: Austria
Authorised representative: SUNGO Europe B.V.
Last updated: 16.07.2026 06:53