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

by Wuhan Easydiagnosis Biomedicine Co., Ltd. China EUDAMED

Ref W-Ag09-B10Model Type:B-10,10 Tests/kit ( Positive and negative controls)

EMDN W0105041101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06978896416561 Basic UDI-DIDate16 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Type:B-10, 10 Tests/kit ( Positive and negative controls), W-Ag09-B10
Primary DI / UDI-DI
06978896416561
Basic UDI-DI
B-06978896416561
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 2fbfc43c-8fb8-42bd-8960-e45d6ec857cf 61 fields · synced 22 Oct 2026