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2019-nCoV Antigen Test (Lateral Flow Method)

by Guangzhou Wondfo Biotech Co., Ltd. China EUDAMED

Ref W634P0024 EMDN W0105090501

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69332898CE1606FH Basic UDI-DIDate8 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED · synced 24 Oct 2026

Device Name
2019-nCoV Antigen Test (Lateral Flow Method)
Model / Reference
W634P0024
Primary DI / UDI-DI
06933289816809
Basic UDI-DI
69332898CE1606FH
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000000689
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Guangzhou Wondfo Biotech Co., Ltd.

See all devices from Guangzhou Wondfo Biotech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06933289816809|69332898CE1606FH 61 fields · synced 24 Oct 2026