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Zenit HEP2 Classifier

by Visia Lab S.r.l. Italy EUDAMED

Ref 49218Model ZENIT HEP2 CLASSIFIER

EMDN W02079082

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number805930434ZENITHEP2CLFU Basic UDI-DIDate12 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Zenit HEP2 Classifier
Model / Reference
ZENIT HEP2 CLASSIFIER, 49218
Primary DI / UDI-DI
08059304340000
Basic UDI-DI
805930434ZENITHEP2CLFU
EMDN Code
W02079082 Various general purpose IVD instruments - software accessories
Device Class
Class B
Special Device Type
Software
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000013016

Other devices from Visia Lab S.r.l.

See all devices from Visia Lab S.r.l. →

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 32dcdc8f-667f-4d76-9b56-1b2078582298 61 fields · synced 22 Oct 2026