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Anti-GBM Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd.

Ref IM4414460, IM4411460, IM4410460, IM4415460Model IM4410460 IM4411460 IM4414460 IM4415460

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69506174IM441460DZ Basic UDI-DI Date30 Apr 2026RegisteredStatusActive
European UnionCE/IVDR Number69506174IM441460DZ Basic UDI-DI Date30 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device Name
Anti-GBM Antibody Chemiluminescent Immunoassay Kit
Model / Reference
IM4410460 IM4411460 IM4414460 IM4415460, IM4414460, IM4411460, IM4410460, IM4415460
Primary DI / UDI-DI
06950617403661, 06950617403654, D-IM4410460HZ, D-IM4414460JV, 06950617403647, 06950617403678
Basic UDI-DI
69506174IM441460DZ, B-IM4410460HZ, B-IM4414460JV
Direct Marketing DI
06950617403661
06950617403654
06950617403647
06950617403678
EMDN Code
W0102109014 Antibodies to glomerular basal membrane
Device Class
Class B
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent NoEUDAMEDYesEUDAMED
  • Professional Testing NoEUDAMEDYesEUDAMED
  • Surgical Instrument YesEUDAMEDNoEUDAMED

Other properties (7)

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