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AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)

by Xiamen BioRay Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref HR0504003

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06977194141540 Basic UDI-DIDate25 Oct 2025RegisteredStatusActive

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  • Withdrawn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
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)
Model / Reference
HR0504003
Primary DI / UDI-DI
06977194141540
Basic UDI-DI
B-06977194141540
EMDN Code
W0102160299 Tumour marker 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

Other devices from Xiamen BioRay Biotechnology Co., Ltd.

See all devices from Xiamen BioRay Biotechnology 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