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PoET HCV

by Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH Germany EUDAMED

Ref P2A-28-30

EMDN W0105020307

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04262353370032 Basic UDI-DIDate18 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
P2A-28-30
Primary DI / UDI-DI
04262353370032
Basic UDI-DI
B-04262353370032
EMDN Code
W0105020307 Hepatitis c virus - na reagents
Device Class
Class IVD Annex II List A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000025295

Other devices from Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH

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Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 19c50269-ef13-4f50-a7a1-5864144ca009 61 fields · synced 22 Oct 2026