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immuClone (1) Anti-E IgM

by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED

Ref 0007406

EMDN W0103030202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIX 1191616-7 Date9 Apr 2026IssuedStatusActive expires 24 Oct 2028

Coverage

1 jurisdiction

IcelandNorwaySwedenFinlandFinlandNorwaySwedenFinlandFinlandNorwaySwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceLiechtensteinAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalyTürkiyeTürkiyeSpainSpainCroatiaGreeceTürkiyeTürkiyeTürkiyeTürkiyeMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

EU market availability

Available in 32 countries, as listed in EUDAMED:

  • Austriasince 20 Jan 2004
  • Belgiumsince 20 Jan 2004
  • Bulgariasince 20 Jan 2004
  • Croatiasince 20 Jan 2004
  • Cyprussince 20 Jan 2004
  • Czechiasince 20 Jan 2004
  • Denmarksince 20 Jan 2004
  • Estoniasince 20 Jan 2004
  • Finlandsince 20 Jan 2004
  • Francesince 20 Jan 2004
  • Germanysince 20 Jan 2004
  • Greecesince 20 Jan 2004
  • Hungarysince 20 Jan 2004
  • Icelandsince 20 Jan 2004
  • Irelandsince 20 Jan 2004
  • Italysince 20 Jan 2004
  • Latviasince 20 Jan 2004
  • Liechtensteinsince 20 Jan 2004
  • Lithuaniasince 20 Jan 2004
  • Luxembourgsince 20 Jan 2004
  • Maltasince 20 Jan 2004
  • Netherlandssince 20 Jan 2004
  • Northern Irelandsince 20 Jan 2004
  • Norwaysince 20 Jan 2004
  • Polandsince 20 Jan 2004
  • Portugalsince 20 Jan 2004
  • Romaniasince 20 Jan 2004
  • Slovakiasince 20 Jan 2004
  • Sloveniasince 20 Jan 2004
  • Spainsince 20 Jan 2004
  • Swedensince 20 Jan 2004
  • Türkiyesince 20 Jan 2004

Last checked 23 Oct 2026.

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 23 Oct 2026

Device Name
immuClone (1) Anti-E IgM and Galileo
Model / Reference
0007406
Primary DI / UDI-DI
10888234300434, 04042091000183
Basic UDI-DI
88823405W0103030202D24JF, 40420910002E2N
Direct Marketing DI
10888234300434
04042091000183
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 NoEUDAMEDYesEUDAMED
  • 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 (2)

  • EUDAMED ca1fb859-eed3-4b41-a30c-bc57fa5343c8 61 fields · synced 23 Oct 2026
  • EUDAMED 04042091000183|40420910002E2N 61 fields · synced 14 Oct 2026