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RF-IgA Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 7 variants

Ref IM4406271Model IM4402271 IM4403271 IM4406271 IM4407271 IM4410271 IM4411271 IM4414271 IM4415271

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 Number69506174IM440271DM Basic UDI-DI Date29 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  • Withdrawn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
RF-IgA Chemiluminescent Immunoassay Kit
Model / Reference
IM4402271 IM4403271 IM4406271 IM4407271 IM4410271 IM4411271 IM4414271 IM4415271, IM4406271
Primary DI / UDI-DI
06950617433750, D-IM4406271JT
Basic UDI-DI
69506174IM440271DM, B-IM4406271JT
Direct Marketing DI
06950617433750
EMDN Code
W01021199, W01021110
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

  • Human Tissues
  • 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