Skip to content

COVID-19 Ag Test

by Abiores Technology (Beijing) Co., Ltd. China EUDAMED

Ref ACA21B004-001DModel Cassette EMDN W0105099099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06958982140921 Basic UDI-DIDate6 Aug 2026RegisteredStatusActive

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  • Withdrawn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 · synced 24 Oct 2026

Model / Reference
Cassette, ACA21B004-001D
Primary DI / UDI-DI
06958982140921
Basic UDI-DI
B-06958982140921
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000022952
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Abiores Technology (Beijing) Co., Ltd.

See all devices from Abiores Technology (Beijing) Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 06958982140921|B-06958982140921 61 fields · synced 24 Oct 2026