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Rotavirus & Adenovirus Antigen Rapid Test Cassette (Colloidal Gold)

by Dezhou Guoke Medical Technology Co., Ltd.

Ref GKPD041Model 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box

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-06977698402239 Basic UDI-DI 06977698402239UDI-DIDate8 Apr 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  • Withdrawn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

Model / Reference
1T/box, 10T/box, 20T/box, 25T/box, 40T/box, 50T/box, GKPD041
Primary DI / UDI-DI
06977698402239
Basic UDI-DI
B-06977698402239
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000044128
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Dezhou Guoke Medical Technology Co., Ltd.

See all devices from Dezhou Guoke Medical Technology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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