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T3/T4/TSH Combo Test Kit (Fluorescence Immunochromatographic Assay)

by Diasia Biomedical Technology Co., Ltd. EUDAMED

Active European Union

Ref R331180Model 10 Tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973316743517 Basic UDI-DIDate17 Apr 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  • Withdrawn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

Device Name
T3/T4/TSH Combo Test Kit (Fluorescence Immunochromatographic Assay)
Model / Reference
10 Tests/kit, R331180
Primary DI / UDI-DI
06973316743517
Basic UDI-DI
B-06973316743517
EMDN Code
W01020499 Thyroid hormones - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000010281
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Diasia Biomedical Technology Co., Ltd.

See all devices from Diasia Biomedical Technology Co., Ltd. →

Properties

  • 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