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Thyroid Hormone (TT4) Test Kit (Fluorescence immunochromatography method)

by Biobase Poct Co., Ltd China EUDAMED

Ref 20 tests / kit（DR055-4）Model 20 tests / kit

EMDN W0102160999

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976374751258 Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
20 tests / kit, 20 tests / kit（DR055-4）
Primary DI / UDI-DI
06976374751258
Basic UDI-DI
B-06976374751258
EMDN Code
W0102160999 Individual and specific hormones/proteins rt & poc - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000045945
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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See all devices from Biobase Poct Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 64d42f27-5bc9-4026-9b56-fffa71d69d1c 61 fields · synced 22 Oct 2026