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RF Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 6 variants

Ref IM4415268Model IM4402268 IM4403268 IM4406268 IM4407268 IM4410268 IM4411268 IM4414268 IM4415268

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/IVDR NumberB-IM4415268KA Basic UDI-DI Date23 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-IM4415268KA Basic UDI-DI Date23 May 2022RegisteredStatusActive

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  • Withdrawn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, CE/IVDD Active

Specification

EUDAMED

Device Name
RF Chemiluminescent Immunoassay Kit
Model / Reference
IM4415268, IM4402268 IM4403268 IM4406268 IM4407268 IM4410268 IM4411268 IM4414268 IM4415268
Primary DI / UDI-DI
D-IM4415268KA, 06950617403920
Basic UDI-DI
B-IM4415268KA, 69506174IM441268E7
Direct Marketing DI
06950617403920
EMDN Code
W01021110 Rheumatoid factors
Device Class
Class IVD General
Class B
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Maccura Biotechnology Co., Ltd.

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

Properties

  • Human Tissues YesEUDAMEDNoEUDAMED
  • Animal Tissues
  • 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