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SARS-CoV-2 Antigen Rapid Test Cassette

by Sejoy Biomedical Co., Ltd.

Ref COVG-602

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06939663977517 Basic UDI-DI Date24 Sep 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  • Withdrawn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
COVG-602
Primary DI / UDI-DI
06939663977517, 06939663977104
Basic UDI-DI
B-06939663977517, B-06939663977104
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000008447
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No