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Anti-Wr(a) monoclonal IgG

by ANTITOXIN GmbH Germany EUDAMED

Ref 01.255-02

EMDN W01030399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4250861801.255KP Basic UDI-DIDate3 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
01.255-02
Primary DI / UDI-DI
04250861821535
Basic UDI-DI
4250861801.255KP
EMDN Code
W01030399 Immunohaematology (blood grouping) tests - other
Device Class
Class C
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
DE-MF-000008156

Properties & raw data

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

Sources (1)

  • EUDAMED 88445f6c-868a-4d76-98ec-72434661ae15 61 fields · synced 22 Oct 2026