Skip to content

COVID-19 (SARS-CoV-2) Antigen Test Kit

by Hangzhou Fanttest Biotech Co., Ltd.

Ref ICO-A502-A1, ICO-A502-P1Model 1 test

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-06974408020011 Basic UDI-DI Date2 Jan 2024RegisteredStatusActive

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  • Withdrawn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
1 test, ICO-A502-A1, ICO-A502-P1
Primary DI / UDI-DI
06974408020011, 06974408020059
Basic UDI-DI
B-06974408020011, B-06974408020059
EMDN Code
W0105040519
Device Class
Class IVD devices for self-testing
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000026134
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hangzhou Fanttest Biotech Co., Ltd.

See all devices from Hangzhou Fanttest Biotech Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Self Testing

Other properties (7)

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