Skip to content

Rapid nCoV & FluA/B Ag Test Kit (Colloidal Gold)

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

Ref REF206-001

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974831192057 Basic UDI-DI 06974831192057UDI-DIDate27 May 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Rapid nCoV & FluA/B Ag Test Kit (Colloidal Gold)
Model / Reference
REF206-001
Primary DI / UDI-DI
06974831192057
Basic UDI-DI
B-06974831192057
EMDN Code
W0105090601 Coronavirus / influenza - rt & poc
Device Class
Class IVD General
EU market of registration
Romania

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

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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