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Yourgene® Cystic Fibrosis Base

by Yourgene Health UK Ltd United Kingdom EUDAMED

Ref CF2EUB2 EMDN W0106010101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number506040268CFLR Basic UDI-DIDate22 May 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  • Withdrawn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 25 Oct 2026

Device Name
Yourgene® Cystic Fibrosis
Model / Reference
CF2EUB2
Primary DI / UDI-DI
05060402680007
Basic UDI-DI
506040268CFLR
EMDN Code
W0106010101 Cystic fibrosis
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 03f41706-923c-4c7f-87f1-48a60055ef48 61 fields · synced 25 Oct 2026