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NGSengine®

by Genome Diagnostics B.V. Netherlands EUDAMED

Ref 4949940, 4949740, 4949840, 4949640 EMDN W02050192

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number871846936ngsengineX5 Basic UDI-DIDate26 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
NGSengine
Model / Reference
4949940, 4949740, 4949840, 4949640
Primary DI / UDI-DI
08718469360642
Basic UDI-DI
871846936ngsengineX5
Direct Marketing DI
08718469360642
EMDN Code
W02050192 Nucleic acid testing instruments except micro-arrays - IVD medical device software
Device Class
Class C
Special Device Type
Software
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
NL-MF-000000453

Other devices from Genome Diagnostics B.V.

See all devices from Genome Diagnostics B.V. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
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
  • New Device: No

Sources (1)

  • EUDAMED 6aa61f08-1507-4a62-a770-0f136bd0274c-1 61 fields · synced 22 Oct 2026