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immuClone® (1) Anti-e IgM

by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED

Ref 0007516

EMDN W0103030202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number40420910003E2R Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 23 Oct 2026

Device Name
immuClone (1) Anti-e IgM and Galileo
Model / Reference
0007516
Primary DI / UDI-DI
04042091000244
Basic UDI-DI
40420910003E2R
Direct Marketing DI
04042091000244
EMDN Code
W0103030202 Rhesus phenotypes
Device Class
Class D
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 75bef9c7-3425-4b1f-bfac-cfb9f0f62ab7 61 fields · synced 23 Oct 2026