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Niptify

by Celvia CC AS Estonia EUDAMED

Ref NIPTIFYModel NIPTIFY Focus Plus

EMDN W0106010399

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-NIPT17692GH Basic UDI-DIDate5 Feb 2025RegisteredStatusActive

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

Device Name
NIPTIFY test
Model / Reference
NIPTIFY Focus Plus, NIPTIFY
Primary DI / UDI-DI
D-NIPT17692GH
Basic UDI-DI
B-NIPT17692GH
EMDN Code
W0106010399 Chromosomal disorders tests - other
Device Class
Class IVD General
Market of Registration
Estonia

Manufacturer details

EUDAMED SRN
EE-MF-000045569

Other devices from Celvia CC AS

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 47d34f34-6568-400e-8779-f4328f0c34b6 61 fields · synced 22 Oct 2026