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Total T4 Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4406053Model IM4405053 IM4401053 IM4406053 IM4404053

EMDN W01020407

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM440053D9 Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Total T4 Chemiluminescent Immunoassay Kit
Model / Reference
IM4405053 IM4401053 IM4406053 IM4404053, IM4406053
Primary DI / UDI-DI
06950617403302
Basic UDI-DI
69506174IM440053D9
Direct Marketing DI
06950617403302
EMDN Code
W01020407 Thyroxine
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
  • 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

Sources (1)

  • EUDAMED c133e7bf-fbbd-4a98-b128-e8a25aa2f902 61 fields · synced 22 Oct 2026