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immuClone Anti-H IgM

by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED

Ref 0009525 EMDN W0103030102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number40420910005D2V Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
immuClone Anti-H IgM and Galileo
Model / Reference
0009525
Primary DI / UDI-DI
04042091000558
Basic UDI-DI
40420910005D2V
Direct Marketing DI
04042091000558
EMDN Code
W0103030102 Abo sera
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006494

Other devices from IMMUCOR Medizinische Diagnostik GmbH

See all devices from IMMUCOR Medizinische Diagnostik GmbH →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED cc25b5a2-142e-435c-922d-7a7c2664811a 61 fields · synced 22 Oct 2026