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Rheumatoid Control Plus

by Maccura Biotechnology Co., Ltd. 3 variants

Ref IM4495268, IM4498268, IM4491268, IM4494268, IM4497268Model IM4491268 IM4494268 IM4497268 IM4492268 IM4495268 IM4498268

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 Number69506174IM449268FX Basic UDI-DI Date2 May 2026RegisteredStatusActive
European UnionCE/IVDR Number69506174IM449268FX Basic UDI-DI Date2 May 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  • Withdrawn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
Rheumatoid Control Plus
Model / Reference
IM4491268 IM4494268 IM4497268 IM4492268 IM4495268 IM4498268, IM4495268, IM4498268, IM4491268, IM4494268, IM4497268
Primary DI / UDI-DI
06950617402534, 06950617433309, 06950617402572, D-IM4494268MT, 06950617433293, D-IM4491268M6, D-IM4498268NP
Basic UDI-DI
69506174IM449268FX, B-IM4494268MT, B-IM4491268M6, B-IM4498268NP
Direct Marketing DI
06950617402534
06950617433309
06950617402572
06950617433293
EMDN Code
W0102152011, W0102152010
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 NoEUDAMEDYesEUDAMED
  • Animal Tissues
  • Reagent YesEUDAMEDNoEUDAMED
  • 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