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Genedrive® CYP2C19 Collection Kit

by Genedrive Diagnostics Ltd. United Kingdom EUDAMED

Ref CK-CYP2C19-10-TR EMDN W05019099

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506065486CK-CYP2C19-019L Basic UDI-DIDate19 Feb 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CK-CYP2C19-10-TR
Primary DI / UDI-DI
05060654860837
Basic UDI-DI
506065486CK-CYP2C19-019L
Unit of Use DI
05060654860745
EMDN Code
W05019099 Samples collection devices - other
Device Class
Class A
Market of Registration
Türkiye

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED b28b738f-b8ee-4c92-96cf-be30be130117 61 fields · synced 24 Oct 2026