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Thyroid Function Control

by Maccura Biotechnology Co., Ltd. 13 variants

Ref EIM4491051Model EIM4489051 EIM4488051 EIM4487051 EIM4486051 EIM4485051 EIM4484051 EIM4483051 EIM4482051 EIM4481051 EIM4499051 EIM4498051 EIM4497051 EIM4496051 EIM4495051 EIM4494051 EIM4493051 EIM4492051 EIM4491051

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 Number69506174IM449051F4 Basic UDI-DI 06950617402480UDI-DIDate2 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Device Name
Thyroid Function Control
Model / Reference
EIM4489051 EIM4488051 EIM4487051 EIM4486051 EIM4485051 EIM4484051 EIM4483051 EIM4482051 EIM4481051 EIM4499051 EIM4498051 EIM4497051 EIM4496051 EIM4495051 EIM4494051 EIM4493051 EIM4492051 EIM4491051, EIM4491051
Primary DI / UDI-DI
06950617402480
Basic UDI-DI
69506174IM449051F4
Direct Marketing DI
06950617402480
EMDN Code
W0102152099 Controls- immunochemistry - other
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

  • Human Tissues
  • 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