Skip to content

Yourgene® DPYD

by Yourgene Health UK Ltd United Kingdom EUDAMED

Ref ONDYDB1

EMDN W0106030101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506040268ONDYD65 Basic UDI-DIDate10 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
ONDYDB1
Primary DI / UDI-DI
05060402680311
Basic UDI-DI
506040268ONDYD65
EMDN Code
W0106030101 Cyp 450 - individual test
Device Class
Class C
Market of Registration
France

Manufacturer details

EUDAMED SRN
GB-MF-000024810
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Yourgene Health UK Ltd

See all devices from Yourgene Health UK Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED de0d6944-46a2-4b20-a02a-1aa0026f6c83 61 fields · synced 24 Oct 2026