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Nifty®

by Bgi Europe a/S Denmark EUDAMED

Ref MFG030112Model 96 tests

EMDN W0106010306

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number574400351MFG03011085 Basic UDI-DIDate1 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Detection Kit for Noninvasive Fetal Trisomy（T21, T18, T13）Test (Combinatorial Probe-Anchor Synthesis Sequencing Method)
Model / Reference
96 tests, MFG030112
Primary DI / UDI-DI
05744003510306, 05744003510313, 05744003510290
Basic UDI-DI
574400351MFG03011085
EMDN Code
W0106010306 Multiple detection of chromosomal disorders tests
Device Class
Class C
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Other devices from Bgi Europe a/S

See all devices from Bgi Europe a/S →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (3)

  • EUDAMED 7fa42944-b196-4db3-9d8b-0681cfa6b06b 61 fields · synced 23 Oct 2026
  • EUDAMED 05744003510313|574400351MFG03011085 61 fields · synced 9 Oct 2026
  • EUDAMED 05744003510290|574400351MFG03011085 61 fields · synced 9 Oct 2026