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NGEx

by Oncodia AB Sweden EUDAMED

Ref ES-S110FP-C

EMDN W01010499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number735014338ES-S110FP-CE7 Basic UDI-DIDate1 Jun 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
NGEx FFPE DNA Purification Software
Model / Reference
ES-S110FP-C
Primary DI / UDI-DI
17350143380119
Basic UDI-DI
735014338ES-S110FP-CE7
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class A
Special Device Type
Software
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000023836

Other devices from Oncodia AB

  • NGEx

    Class A

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • 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
  • New Device: No

Sources (1)

  • EUDAMED c5787e6b-15a8-44f4-a7b3-f3e7d519b0cc 61 fields · synced 22 Oct 2026