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EIAgen HCV Ab (v.4) Kit

by Adaltis SRL EUDAMED

Active European Union

Ref 071067 / 071064 / 071068Model ++M52107106LG

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-++M52107106LG Basic UDI-DIDate18 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
EIAgen HCV Ab (v.4)
Model / Reference
++M52107106LG, 071067 / 071064 / 071068
Primary DI / UDI-DI
++M52107106LG
Basic UDI-DI
B-++M52107106LG
EMDN Code
W0105020303 Hcv antibody (total)
Device Class
Class IVD Annex II List A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
IT-MF-000028990

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No