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Free Thyroxine Assay Kit(Chemiluminescence Immunoassay)

by Hunan AccuBio Biotech Co., Ltd. EUDAMED

Active European Union

Ref TH004Model 50T

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976964665330 Basic UDI-DIDate20 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
Free Thyroxine Assay Kit(Chemiluminescence Immunoassay)
Model / Reference
50T, TH004
Primary DI / UDI-DI
06976964665330
Basic UDI-DI
B-06976964665330
EMDN Code
W01020402 Free thyroxine
Device Class
Class IVD General
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.

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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