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Anti-K (KEL1) monoclonal, human IgM clone: AEK-4

by ANTITOXIN GmbH Germany EUDAMED

Ref 01.169-05

EMDN W0103030501

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-04250861802213 Basic UDI-DIDate4 Aug 2026RegisteredStatusActive

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 24 Oct 2026

Model / Reference
01.169-05
Primary DI / UDI-DI
04250861802213
Basic UDI-DI
B-04250861802213
EMDN Code
W0103030501 Other antigen typing reagents
Device Class
Class IVD Annex II List A
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000008156

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 589afe6c-b54e-43b4-aab3-827d6bc1f3f7 61 fields · synced 24 Oct 2026