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eVai

by ENGENOME srl Italy EUDAMED

Ref eVai

EMDN W02069092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805620972eVaiQN Basic UDI-DIDate24 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
eVai
Primary DI / UDI-DI
08056209720104
Basic UDI-DI
805620972eVaiQN
Direct Marketing DI
08056209720104
EMDN Code
W02069092 Various sample processing instruments - IVD medical device software
Device Class
Class C
Special Device Type
Software
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IT-MF-000029171

Other devices from ENGENOME srl

  • eVai

    IVD General

Properties & raw data

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

Sources (1)

  • EUDAMED 9a3a6a43-dcb0-4e65-9f72-f5a3899ea310 61 fields · synced 23 Oct 2026