Skip to content

2019-nCoV Antigen Rapid Test (Immunochromatography Assay)

by Shenzhen Superbio Technology Co., Ltd. 3 variants

Ref SUPL010005

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974521001737 Basic UDI-DI Date27 Feb 2023RegisteredStatusActive

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  • Withdrawn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
SUPL010005
Primary DI / UDI-DI
06974521001737, 06974521001706
Basic UDI-DI
B-06974521001737, B-06974521001706
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
Class IVD devices for self-testing
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000024149
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Shenzhen Superbio Technology Co., Ltd.

See all devices from Shenzhen Superbio Technology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing NoEUDAMEDYesEUDAMED
  • Professional Testing YesEUDAMEDNoEUDAMED

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No