Skip to content

NIPT-GeneSGKit CE-IVD 48 Reacciones

by Sistemas Genomicos S.L. EUDAMED

Active European Union

Ref LV3737Model NIPT-GeneSGKit CE-IVD 48 Reacciones

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08436566761222 Basic UDI-DIDate13 Dec 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

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

Specification

EUDAMED

Model / Reference
NIPT-GeneSGKit CE-IVD 48 Reacciones, LV3737
Primary DI / UDI-DI
08436566761222
Basic UDI-DI
B-08436566761222
EMDN Code
W0106010399 Chromosomal disorders tests - other
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000022949

Other devices from Sistemas Genomicos. S.L.

See all devices from Sistemas Genomicos. S.L. →

Properties

  • Reagent
  • Professional Testing

Other properties (8)

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