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NIPT-GeneSGKit CE-IVD 12 Reacciones

by Sistemas Genomicos. S.L.

Ref LV3736Model NIPT-GeneSGKit, NIPT-GeneSGKit CE-IVD 12 Reacciones

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number843656676121K8 Basic UDI-DI 08436566761215UDI-DIDate21 Feb 2024RegisteredStatusActive
European UnionCE/IVDR Number843656676121K8 Basic UDI-DI 08436566761215UDI-DIDate21 Feb 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Model / Reference
NIPT-GeneSGKit, LV3736, NIPT-GeneSGKit CE-IVD 12 Reacciones
Primary DI / UDI-DI
08436566761215
Basic UDI-DI
843656676121K8, B-08436566761215
EMDN Code
W0106010399 Chromosomal disorders tests - other
Device Class
Class C
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
ES-MF-000022949

Other devices from Sistemas Genomicos. S.L.

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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