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IONA® Nx cfDNA Library Prep Dx Kit (96) (including software)

by Yourgene Health UK Ltd EUDAMED

Active European Union

Ref 10141040

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060448710102 Basic UDI-DIDate19 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  • Withdrawn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

Device Name
IONA® Nx cfDNA Library Prep Dx Kit (96) (including software)
Model / Reference
10141040
Primary DI / UDI-DI
05060448710102
Basic UDI-DI
B-05060448710102
EMDN Code
W0106010306 Multiple detection of chromosomal disorders tests
Device Class
Class IVD Annex II List B
Market of Registration
France

Manufacturer details

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

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See all devices from Yourgene Health UK Ltd →

Properties

Show 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