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TSH Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd.

Ref IM4406055, IM4401055, IM4405055, IM4404055Model IM4405055 IM4401055 IM4406055 IM4404055

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 Number69506174IM440055DD Basic UDI-DI Date4 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  • Withdrawn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
TSH Chemiluminescent Immunoassay Kit
Model / Reference
IM4405055 IM4401055 IM4406055 IM4404055, IM4406055, IM4401055, IM4405055, IM4404055
Primary DI / UDI-DI
06950617403500, 06950617403494, 06950617403487, 06950617403517
Basic UDI-DI
69506174IM440055DD
Direct Marketing DI
06950617403500
06950617403494
06950617403487
06950617403517
EMDN Code
W01020410 Thyroid stimulating hormone
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
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (7)

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