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Thyroid Autoantibodies Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref EIM4295503Model EIM4291503 EIM4294503 EIM4297503 EIM4292503 EIM4295503 EIM4298503

EMDN W0102152099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM429503EU Basic UDI-DIDate2 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Thyroid Autoantibodies Control
Model / Reference
EIM4291503 EIM4294503 EIM4297503 EIM4292503 EIM4295503 EIM4298503, EIM4295503
Primary DI / UDI-DI
06950617439325
Basic UDI-DI
69506174IM429503EU
Direct Marketing DI
06950617439325
EMDN Code
W0102152099 Controls- immunochemistry - other
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

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 6fa445e3-5a10-4842-99dc-f238832c7671 61 fields · synced 24 Oct 2026