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Pirkko

by Integritas Oy Finland EUDAMED

Ref PIRKKO

EMDN Z129092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-PIRKKOP8 Basic UDI-DIDate7 Apr 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
PIRKKO
Primary DI / UDI-DI
D-PIRKKOP8
Basic UDI-DI
B-PIRKKOP8
EMDN Code
Z129092 Various instruments for functional exploration and therapeutic interventions - medical device software
Device Class
Class I
Special Device Type
-1192
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000012405

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED b0e251bc-299b-484c-b1ed-cce94b1b2849 61 fields · synced 22 Oct 2026