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PGx SW Engine

by Abomics Oy Finland EUDAMED

Ref 69830067

EMDN V92

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6430069830069830067GQ Basic UDI-DIDate10 May 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
69830067
Primary DI / UDI-DI
06430069830067
Basic UDI-DI
6430069830069830067GQ
Direct Marketing DI
06430069830067
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class C
Special Device Type
Software
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000018041

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Companion Diagnostics
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED a5f5c363-e741-4759-a663-7e9b4df96450 61 fields · synced 24 Oct 2026