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Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

by GeneMind Biosciences Co., Ltd. EUDAMED

Active European Union

Ref L000159-PModel 48tests/kit (Pre-packaged)

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974968584282 Basic UDI-DIDate7 Jul 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  • Withdrawn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
48tests/kit (Pre-packaged), L000159-P
Primary DI / UDI-DI
06974968584282
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000025785
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

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