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SARS-CoV-2 Antigen Test Kit (Colloidal Gold)

by Shenzhen Huian Biosci Technology Co., Ltd. 2 variants

Ref ST-007, ST-001, ST-020, ST-025, ST-002

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974831192309 Basic UDI-DI Date2 Jun 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  • Withdrawn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

Device Name
SARS-CoV-2 Antigen Test Kit (Colloidal Gold)
Model / Reference
ST-007, ST-001, ST-020, ST-025, ST-002
Primary DI / UDI-DI
06974831192309, 06974831192279, 06974831192316, 06974831192323, 06974831192286
Basic UDI-DI
B-06974831192309, B-06974831192279, B-06974831192316, B-06974831192323, B-06974831192286
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD devices for self-testing
EU market of registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000028080
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Shenzhen Huian Biosci Technology Co., Ltd.

See all devices from Shenzhen Huian Biosci Technology Co., Ltd. →

Properties

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

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No