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NanoTYPER

by Omixon Biocomputing Ltd. Hungary EUDAMED

Ref SW6Model NanoTYPER EMDN W02050192

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number599956578002TX Basic UDI-DIDate15 Oct 2024RegisteredStatusActive

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  • Withdrawn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 24 Oct 2026

Device Name
NanoTYPER 2.2.0 CE
Model / Reference
NanoTYPER, SW6
Primary DI / UDI-DI
05999565781354
Basic UDI-DI
599956578002TX
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
Hungary

Manufacturer details

EUDAMED SRN
HU-MF-000003018

Other devices from Omixon Biocomputing Ltd.

See all devices from Omixon Biocomputing Ltd. →

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 4b485b1c-f49b-4123-9d75-718796d2163a 61 fields · synced 24 Oct 2026