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

by Wuhan Easydiagnosis Biomedicine Co., Ltd. 11 variants

Ref W-AgH-02SModel Type:B-2 Tests/Kit Type S

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06978896417568 Basic UDI-DI 06978896417568UDI-DIDate29 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
Type:B-2 Tests/Kit Type S, W-AgH-02S
Primary DI / UDI-DI
06978896417568
Basic UDI-DI
B-06978896417568
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD devices for self-testing
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000019908
Authorised representative
OSMUNDA Medical Technology Service GmbH DE-AR-000009285

Other devices from Wuhan Easydiagnosis Biomedicine Co., Ltd.

See all devices from Wuhan Easydiagnosis Biomedicine Co., Ltd. →

Properties

  • Microbial Substances
  • Reagent
  • Self Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No