Skip to content

immuClone® Anti-D fast IgM

by IMMUCOR Medizinische Diagnostik GmbH Germany EUDAMED

Ref 0007116 EMDN W0103030201

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberIX 1191616-16 Date9 Apr 2026IssuedStatusActive expires 29 Oct 2028

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IX 1191616-16 Supplemented

    Technical documentation EU IVDR

    Notified body
    TÜV Rheinland LGA Products GmbH 0197
    Issued
    9 Apr 2026
    Expires
    29 Oct 2028
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
0007116
Primary DI / UDI-DI
10888234300236, 04042091000060
Basic UDI-DI
88823405W0103030201D37JH, 40420910010E2M
Direct Marketing DI
10888234300236
04042091000060
EMDN Code
W0103030201 Rhesus d
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 NoEUDAMEDYesEUDAMED
  • 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 6e468f32-39da-46f7-8c6a-87fa0cdfc96c 61 fields · synced 24 Oct 2026
  • EUDAMED 04042091000060|40420910010E2M 61 fields · synced 24 Oct 2026