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Total Thyroxine（TT4）Determination Kit（ Chemiluminescence Immunoassay ）

by Shenzhen Channel Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref CR004EU01Model 10 Tests/Kit or 20 Tests/Kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968300619 Basic UDI-DIDate27 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
10 Tests/Kit or 20 Tests/Kit, CR004EU01
Primary DI / UDI-DI
06976968300619
Basic UDI-DI
B-06976968300619
EMDN Code
W01020407 Thyroxine
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000053778
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Shenzhen Channel Biotechnology Co., Ltd.

See all devices from Shenzhen Channel Biotechnology Co., Ltd. →

Properties

Show properties
  • Reagent
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No