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Yourgene® Cystic Fibrosis Lite

by Yourgene Health UK Ltd EUDAMED

Active European Union

Ref CF4HTB1

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060402680014 Basic UDI-DIDate13 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
CF4HTB1
Primary DI / UDI-DI
05060402680014
Market of Registration
Ireland

Manufacturer details

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

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