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Yourgene® Cystic Fibrosis Plus Italian

by Yourgene Health UK Ltd

Ref CFITAB1

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060402680281 Basic UDI-DI 05060402680281UDI-DIDate27 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
CFITAB1
Primary DI / UDI-DI
05060402680281
Basic UDI-DI
B-05060402680281
EMDN Code
W0106010101 Cystic fibrosis
Device Class
Class IVD General
EU market of registration
Italy

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

  • Human Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No