Skip to content

SARS-CoV-2 Ag Test

by Aceso Laboratories, Inc. EUDAMED

Active European Union

Ref OF02-COV

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-OF02-COV6F Basic UDI-DIDate16 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
SARS-CoV-2 Ag Test
Model / Reference
OF02-COV
Primary DI / UDI-DI
D-OF02-COV6F
Basic UDI-DI
B-OF02-COV6F
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
US-MF-000045175
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

Other devices from Aceso Laboratories, Inc.

See all devices from Aceso Laboratories, Inc. →

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