Skip to content

Gardnerella vaginalis Antigen Rapid Test

by Medotex Biotech (HangZhou) Co., Ltd.

Ref GV-502a

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GV-502aPC Basic UDI-DI D-GV-502aPCUDI-DIDate9 Jun 2026RegisteredStatusActive

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  • Withdrawn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
Gardnerella vaginalis Antigen Rapid Test
Model / Reference
GV-502a
Primary DI / UDI-DI
D-GV-502aPC
Basic UDI-DI
B-GV-502aPC
EMDN Code
W0105011799, W0105090199
Device Class
Class IVD General
EU market of registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000051631
Authorised representative
HUMISS TRADING S. L. ES-AR-000040177

Other devices from Medotex Biotech (HangZhou) Co., Ltd.

See all devices from Medotex Biotech (HangZhou) Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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