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TSH Rapid Quantitative Test (Chemiluminescence Immunoassay)

by Xiamen BioRay Biotechnology Co., Ltd. China EUDAMED

Ref HR0512003

EMDN W0102160999

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977194142073 Basic UDI-DIDate25 Oct 2025RegisteredStatusActive

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

Device Name
TSH Rapid Quantitative Test (Chemiluminescence Immunoassay)
Model / Reference
HR0512003
Primary DI / UDI-DI
06977194142073
Basic UDI-DI
B-06977194142073
EMDN Code
W0102160999 Individual and specific hormones/proteins rt & poc - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000045502
Authorised representative
Medunion S.L. ES-AR-000019366

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 826b3824-f34a-4c46-bcaa-4a2858f018db 61 fields · synced 22 Oct 2026