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Kliiniset Suositukset

by Oy Apotti Ab EUDAMED

Active European Union

Ref Kliiniset Suositukset

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number643008136MDBPA42 Basic UDI-DIDate28 Nov 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI25/00000062 Issued

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    23 Oct 2025
    Expires
    23 Oct 2028
    Valid from
    24 Oct 2025

Specification

EUDAMED

Model / Reference
Kliiniset Suositukset
Primary DI / UDI-DI
06430081360023
Basic UDI-DI
643008136MDBPA42
Direct Marketing DI
06430081360023
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000007544

Other devices from Oy Apotti Ab

See all devices from Oy Apotti Ab →

Properties

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