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omnomicsNGS

by Euformatics Oy EUDAMED

Active European Union

Ref 06429811494008

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06429811494008 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06429811494008 Basic UDI-DIDate24 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR, CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Trade Name
omnomicsNGS
omnomicaNGS
Model / Reference
06429811494008
Primary DI / UDI-DI
06429811494008
Basic UDI-DI
B-06429811494008, 6429811494oNGSHS
Direct Marketing DI
06429811494008
EMDN Code
W02079092 Various general purpose IVD instruments - IVD medical device software
Device Class
Class IVD General
Class C
Special Device Type
-1202
Software
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000030204

Properties

  • 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