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COVID-19 (SARS-CoV-2) Antigen Test Kit

by Wuhan Easydiagnosis Biomedicine Co., Ltd. EUDAMED

Active European Union

Ref W-Ag09-B01

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978896416745 Basic UDI-DIDate17 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
W-Ag09-B01
Primary DI / UDI-DI
06978896416745
Basic UDI-DI
B-06978896416745
EMDN Code
W0105041101 Coronavirus ag
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019908
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Wuhan Easydiagnosis Biomedicine Co., Ltd.

See all devices from Wuhan Easydiagnosis Biomedicine 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