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

by Wuhan Easydiagnosis Biomedicine Co., Ltd. 81 variants

Ref W-Ag01-B05Model Type:B-5,5 Tests/kit (Anterior nasal swab (short version))

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978896416738 Basic UDI-DI 06978896416738UDI-DIDate17 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
Type:B-5, 5 Tests/kit (Anterior nasal swab (short version)), W-Ag01-B05
Primary DI / UDI-DI
06978896416738
Basic UDI-DI
B-06978896416738
EMDN Code
W0105041101 Coronavirus ag
Device Class
Class IVD General
EU 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.

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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