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Chemiluminescence Immunoassay Multi-analytes (CIM) Control

by Maccura Biotechnology Co., Ltd. 3 variants

Ref IM4292501, IM4291501, IM4293502, IM4295502, IM4296502, IM4291502Model IM4295502 IM4294502 IM4292501 IM4291501 IM4292502 IM4291502

Active European Union

CE IVDR

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/IVDR Number69506174IM429502ES 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Chemiluminescence Immunoassay Multi-analytes (CIM) Control
Model / Reference
IM4295502 IM4294502 IM4292501 IM4291501 IM4292502 IM4291502, IM4292501, IM4291501, IM4293502, IM4295502, IM4296502, IM4291502
Primary DI / UDI-DI
06950617404996, D-IM4291501KT, D-IM4293502LB, D-IM4295502LR, D-IM4296502LY, D-IM4292501L2, 06950617405030, 06950617404965, 06950617405009
Basic UDI-DI
69506174IM429502ES, B-IM4291501KT, B-IM4293502LB, B-IM4295502LR, B-IM4296502LY, B-IM4292501L2
Direct Marketing DI
06950617404996
06950617405030
06950617404965
06950617405009
EMDN Code
W01021521 Multicomponent immunochemistry controls
Device Class
Class B
Class IVD General
EU market of registration
Spain
Germany

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

  • Human Tissues
  • Reagent YesEUDAMEDNoEUDAMED
  • Professional Testing

Other properties (8)

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