Skip to content

Total Triiodothyronine Assay Kit（Chemiluminescence Immunoassay）

by Hunan AccuBio Biotech Co., Ltd.

Ref TH003Model 50T

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976964665309 Basic UDI-DI 06976964665309UDI-DIDate20 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Total Triiodothyronine Assay Kit（Chemiluminescence Immunoassay）
Model / Reference
50T, TH003
Primary DI / UDI-DI
06976964665309
Basic UDI-DI
B-06976964665309
EMDN Code
W01020405 Triiodothyronine
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000041914
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Hunan AccuBio Biotech Co., Ltd.

See all devices from Hunan AccuBio Biotech Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No