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Yourgene® QST*R Plus Trisomy 21

by Yourgene Health UK Ltd United Kingdom EUDAMED

Ref AN021BX EMDN W0106010301

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-05060402680137 Basic UDI-DIDate27 Aug 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
AN021BX
Primary DI / UDI-DI
05060402680137
Basic UDI-DI
B-05060402680137
EMDN Code
W0106010301 Down's syndrome
Device Class
Class IVD General
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 05060402680137|B-05060402680137 61 fields · synced 25 Oct 2026