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Genedrive® CYP2C19 Control Kit

by Genedrive Diagnostics Ltd. United Kingdom EUDAMED

Ref CYP2C19-CTRL10-DE

EMDN W0106030101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506065486CYP2C19-CTRL01RT Basic UDI-DIDate2 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
CYP2C19-CTRL10-DE
Primary DI / UDI-DI
05060654860646
Basic UDI-DI
506065486CYP2C19-CTRL01RT
Unit of Use DI
05060654860578
EMDN Code
W0106030101 Cyp 450 - individual test
Device Class
Class A
Market of Registration
Germany

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
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • New Device
Other properties (5)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e735d8ee-5277-49c0-8803-fdf7159c8135 61 fields · synced 22 Oct 2026