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PoET HBV

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

Ref P2B-28-30 EMDN W0105020216

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04262353370049 Basic UDI-DIDate18 Oct 2022RegisteredStatusActive

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  • Withdrawn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 · synced 22 Oct 2026

Model / Reference
P2B-28-30
Primary DI / UDI-DI
04262353370049
Basic UDI-DI
B-04262353370049
EMDN Code
W0105020216 Hepatitis b 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 1ce30615-2656-424e-a090-7bc413ef13c2 61 fields · synced 22 Oct 2026