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abia HEV IgM

by AB Diagnostic Systems GmbH Germany EUDAMED

Ref DK.030.01.3, DK.030.05.3

EMDN W0105020505

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04262351593013 Basic UDI-DIDate27 Aug 2025RegisteredStatusActive

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
DK.030.01.3, DK.030.05.3
Primary DI / UDI-DI
04262351593013, 04262351593051
Basic UDI-DI
B-04262351593013, B-04262351593051
EMDN Code
W0105020505 Hev antibody igm
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000025407

Other devices from AB Diagnostic Systems GmbH

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 4a916ea9-1c42-4c65-b61c-e5c76bf452af 61 fields · synced 22 Oct 2026
  • EUDAMED 04262351593051|B-04262351593051 61 fields · synced 17 May 2026