Skip to content

immuClone (1) Anti-C IgM

by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED

Ref 0007206

EMDN W0103030202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number40420910000E2G Basic UDI-DIDate5 May 2026RegisteredStatusActive

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)
  • IX 1191616-3 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV Rheinland LGA Products GmbH 0197
    Issued
    14 Apr 2026
    Expires
    27 Sep 2028
    Reason
    Other

Specification

EUDAMED · synced 22 Oct 2026

Device Name
immuClone (1) Anti-C IgM and Galileo
Model / Reference
0007206
Primary DI / UDI-DI
04042091000107
Basic UDI-DI
40420910000E2G
Direct Marketing DI
04042091000107
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 7243ef6c-df6a-41c4-a558-a92c8486b241 61 fields · synced 22 Oct 2026