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Reverse Triiodothyronine Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 8 variants

Ref EIM4491364Model EIM4401364 EIM4402364 EIM4405364 EIM4406364 EIM4493364 EIM4490364 EIM4491364 EIM4492364

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 Number69506174IM440364DV Basic UDI-DI 06950617459200UDI-DIDate11 Jun 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  • Withdrawn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
Reverse Triiodothyronine Chemiluminescent Immunoassay Kit
Model / Reference
EIM4401364 EIM4402364 EIM4405364 EIM4406364 EIM4493364 EIM4490364 EIM4491364 EIM4492364, EIM4491364
Primary DI / UDI-DI
06950617459200
Basic UDI-DI
69506174IM440364DV
Direct Marketing DI
06950617459200
EMDN Code
W01020404 Reverse triiodothyronine
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
  • 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