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Lyher

by Hangzhou Laihe Biotech Co., Ltd. China EUDAMED

Ref ICO-502-25Model ICO-502-01; ICO-502-05; ICO-502-20; ICO-502-25; ICO-502-40

EMDN W0105090501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697241261ICO-502BJ Basic UDI-DIDate4 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Novel Coronavirus (COVID-19) Antigen Test Kit (Colloidal Gold)
Model / Reference
ICO-502-01, ICO-502-05, ICO-502-20, ICO-502-25, ICO-502-40
Primary DI / UDI-DI
06972412610716
Basic UDI-DI
697241261ICO-502BJ
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000033566
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Hangzhou Laihe Biotech Co., Ltd.

See all devices from Hangzhou Laihe Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06972412610716|697241261ICO-502BJ 61 fields · synced 25 Oct 2026