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Genedrive® CYP2C19 ID Kit

by Genedrive Diagnostics Ltd. United Kingdom EUDAMED

Ref ID-CYP2C19-10-FR EMDN W0106030101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberITDA/00006/0v003 Date16 Jan 2026IssuedStatusActive expires 27 May 2030

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • ITDA/00006/0v003 Amended

    Technical documentation EU IVDR

    Notified body
    QMD Services GmbH 2962
    Issued
    16 Jan 2026
    Expires
    27 May 2030
    Reason
    Other

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
ID-CYP2C19-10-FR
Primary DI / UDI-DI
05060654860493
Basic UDI-DI
506065486ID-CYP2C19-0197
Unit of Use DI
05060654860479
EMDN Code
W0106030101 Cyp 450 - individual test
Device Class
Class C
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 & 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 aaf14f12-d1d2-4331-a606-94fd37c6b1db 61 fields · synced 24 Oct 2026