Skip to content

Navigaattoripalvelu

by DigiFinland Oy EUDAMED

Active European Union

Ref Navi01Model Navigaattoripalvelu

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberFI22/871876 Date2 Sep 2026IssuedStatusActive expires 15 May 2028

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • FI22/871876 Active Supplemented

    Quality management system EU MDR

    Notified body
    SGS FIMKO OY 0598
    Issued
    2 Sep 2026
    Expires
    15 May 2028
    Valid from
    3 Sep 2026
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
Navigaattoripalvelu, Navi01
Primary DI / UDI-DI
06429810539038
Basic UDI-DI
6429810539Navi01YG
Direct Marketing DI
06429810539038
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIb
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000002451

Other devices from DigiFinland Oy

  • Omaolo

    Class IIb

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