Skip to content

Irma

by Forsante Oy Finland EUDAMED

Ref IRMAModel 1.1.x.x

EMDN Z129092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number06429810731043MY Basic UDI-DIDate30 Mar 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
1.1.x.x, IRMA
Primary DI / UDI-DI
06429810731050
Basic UDI-DI
06429810731043MY
Direct Marketing DI
06429810731050
EMDN Code
Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000008137

Other devices from Forsante Oy

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 8b7f1362-36b2-4133-9454-dc6073954073 61 fields · synced 22 Oct 2026