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OMNI360 Kertomus

by CGI Suomi Oy EUDAMED

Active European Union

Ref OMNI360 Kertomus version 1.0

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-OMNI360Kertomus1.06K Basic UDI-DIDate22 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
OMNI360 Kertomus / version 1.1 (several versions available)
Model / Reference
OMNI360 Kertomus version 1.0
Primary DI / UDI-DI
D-OMNI360Kertomus1.06K
Basic UDI-DI
B-OMNI360Kertomus1.06K
EMDN Code
Z12040292 General medicine therapeutic treatment instruments - medical device software
Device Class
Class I
Special Device Type
-1192
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000012661

Other devices from CGI Suomi Oy

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No