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immuClone (2) Anti-c IgM

by IMMUCOR Medizinische Diagnostik GmbH 4 variants

Ref 0007305

Active European Union

CE IVDR

Valid until

27 Sep 2028

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV Rheinland LGA Products GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIX 1191616-6 Date9 Apr 2026IssuedStatusActive expires 27 Sep 2028

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IX 1191616-6 Active Supplemented

    Technical documentation EU IVDR

    Certifier
    TÜV Rheinland LGA Products GmbH 0197
    Issued
    9 Apr 2026
    Expires
    27 Sep 2028
    Reason
    Other

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
0007305
Primary DI / UDI-DI
10888234300366
Basic UDI-DI
88823405W0103030202D28JP
Direct Marketing DI
10888234300366
EMDN Code
W0103030202 Rhesus phenotypes
Device Class
Class D
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006494

Other devices from IMMUCOR Medizinische Diagnostik GmbH

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No