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STANDARD™ Q COVID-19 Ag Home Test

by SD Biosensor Inc.

Ref Q-NCOV-03G/ 09COV130JModel Q-NCOV-03G

Active European Union

CE IVDR

Valid until

14 Jul 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

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/IVDR NumberV76 075369 0076 Date15 Jul 2026IssuedStatusActive expires 14 Jul 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
Q-NCOV-03G, Q-NCOV-03G/ 09COV130J
Primary DI / UDI-DI
08800111725760
Basic UDI-DI
88001117ISCA01QA032G
EMDN Code
W0105090501 Coronavirus antigen (ag) - rt & poc
Device Class
Class C
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
KR-MF-000009168
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Sd Biosensor

See all devices from Sd Biosensor →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Self Testing
  • Near-Patient Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No