Skip to content

eVai

by ENGENOME srl Italy EUDAMED

Ref 80562097200122

EMDN W02079082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-80562097200122 Basic UDI-DIDate14 Oct 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
80562097200122
Primary DI / UDI-DI
80562097200122
Basic UDI-DI
B-80562097200122
EMDN Code
W02079082 Various general purpose IVD instruments - software accessories
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029171

Other devices from ENGENOME srl

  • eVai

    Class C

Properties & raw data

Show properties, registry sources and raw records
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED fd2910ce-dda9-44d5-aa90-b91a33f4dfe2 61 fields · synced 22 Oct 2026