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25-OH Vitamin D Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 6 variants

Ref EIM4401048Model EIM4401048 EIM4402048 EIM4406048 EIM4407048 EIM4412048 EIM4413048

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 Number69506174IM440048DG Basic UDI-DI 06950617444992UDI-DIDate12 Jun 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  • Withdrawn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
25-OH Vitamin D Chemiluminescent Immunoassay Kit
Model / Reference
EIM4401048 EIM4402048 EIM4406048 EIM4407048 EIM4412048 EIM4413048, EIM4401048
Primary DI / UDI-DI
06950617444992
Basic UDI-DI
69506174IM440048DG
Direct Marketing DI
06950617444992
EMDN Code
W0102060309 25-hydroxyvitamin d
Device Class
Class B
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
  • Professional Testing

Other properties (8)

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