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Genedrive® CYP2C19 Collection Kit

by Genedrive Diagnostics Ltd. 10 variants

Ref CK-CYP2C19-10-FR

Active European Union

CE IVDR

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/IVDR Number506065486CK-CYP2C19-019L Basic UDI-DI 05060654860769UDI-DIDate19 Feb 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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
CK-CYP2C19-10-FR
Primary DI / UDI-DI
05060654860769
Basic UDI-DI
506065486CK-CYP2C19-019L
Unit of Use DI
05060654860745
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
GB-MF-000012810
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Genedrive Diagnostics Ltd

See all devices from Genedrive Diagnostics Ltd →

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • New Device

Other properties (7)

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