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Agile-NIPT for MGI CE-IVD 48 Reacciones.

by Sistemas Genomicos S.L. Spain EUDAMED

Ref LV4615Model Agile-NIPT for MGI CE-IVD 48 Reacciones.

EMDN W0106010399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08436566763165 Basic UDI-DIDate16 Dec 2022RegisteredStatusActive

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

Model / Reference
Agile-NIPT for MGI CE-IVD 48 Reacciones., LV4615
Primary DI / UDI-DI
08436566763165
Basic UDI-DI
B-08436566763165
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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED e1773d6e-b654-4408-88ba-b45e59e350a5 61 fields · synced 22 Oct 2026