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IONA® Test AR (including software)

by Yourgene Health UK Ltd United Kingdom EUDAMED

Ref 10141020

EMDN W0106010306

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060448710058 Basic UDI-DIDate19 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
IONA® Test AR (including software)
Model / Reference
10141020
Primary DI / UDI-DI
05060448710058
Basic UDI-DI
B-05060448710058
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

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 (6)
  • Sterile: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED d4a34c33-08ad-4034-9779-771d94924238 61 fields · synced 22 Oct 2026