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Thyroglobulin Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref IM4403059Model IM4402059 IM4403059 IM4406059 IM4407059

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM440059DM Basic UDI-DIDate5 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Thyroglobulin Chemiluminescent Immunoassay Kit
Model / Reference
IM4402059 IM4403059 IM4406059 IM4407059, IM4403059
Primary DI / UDI-DI
06950617403456
Basic UDI-DI
69506174IM440059DM
Direct Marketing DI
06950617403456
EMDN Code
W01020408 Thyroglobulin
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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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