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Thyroid-Stimulating Hormone (TSH) Determination Kit (Chemiluminescence Immunoassay)

by Shenzhen Channel Biotechnology Co., Ltd. China EUDAMED

Ref CR005EU01Model 10 Tests/Kit or 20 Tests/Kit EMDN W01020410

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976968300626 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
10 Tests/Kit or 20 Tests/Kit, CR005EU01
Primary DI / UDI-DI
06976968300626
Basic UDI-DI
B-06976968300626
EMDN Code
W01020410 Thyroid stimulating hormone
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06976968300626|B-06976968300626 61 fields · synced 25 Oct 2026