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NGEx

by Oncodia AB Sweden EUDAMED

Ref ES-K110FP-C

EMDN W01010499

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number735014338NGExFFPEDNADX Basic UDI-DIDate18 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
NGEx FFPE DNA Purification Kit
Model / Reference
ES-K110FP-C
Primary DI / UDI-DI
17350143380010
Basic UDI-DI
735014338NGExFFPEDNADX
EMDN Code
W01010499 Multiple clin. chem lab reagents - other
Device Class
Class A
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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 2c137c95-94d9-489d-8b2c-7779fcf32f1f 61 fields · synced 24 Oct 2026