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Bgi

by Bgi Europe a/S Denmark EUDAMED

Ref HKM910001Model 1 tube/kit

EMDN W050101010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number5745000468HKM910001MS Basic UDI-DIDate11 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Non-Invasive Fetal Trisomy (NIFTY) Test Sample Collection Kit
Model / Reference
1 tube/kit, HKM910001
Primary DI / UDI-DI
05745000468164
Basic UDI-DI
5745000468HKM910001MS
EMDN Code
W050101010201 Blood collection, tubes with additives or serum separator
Device Class
Class A
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000014089

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 43787f53-d69d-442b-92ae-54c769cc4536 61 fields · synced 22 Oct 2026