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Thyroid‑stimulating hormone Receptor Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 7 variants

Ref EIM4405250Model EIM4401250 EIM4402250 EIM4405250 EIM4406250 EIM4409250 EIM4410250 EIM4411250

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 Number69506174IM440250DD Basic UDI-DI 06950617419969UDI-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  • Withdrawn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
Thyroid‑stimulating hormone Receptor Antibody Chemiluminescent Immunoassay Kit
Model / Reference
EIM4401250 EIM4402250 EIM4405250 EIM4406250 EIM4409250 EIM4410250 EIM4411250, EIM4405250
Primary DI / UDI-DI
06950617419969
Basic UDI-DI
69506174IM440250DD
Direct Marketing DI
06950617419969
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
  • 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