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Omaolo

by DigiFinland Oy

Ref Oma02, Oma01Model Omaolo

Active European Union

CE MDR

Valid until

15 May 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS FIMKO OY

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

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

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Omaolo, Oma02, Oma01
Primary DI / UDI-DI
06429810539045, D-FIMF000002451OMA01000XF, 06429810539021, 06429810539007, 06429810539014
Basic UDI-DI
6429810539Oma02H3, B-FIMF000002451OMA01000XF, 6429810539Oma01GZ
Direct Marketing DI
06429810539045
06429810539021
06429810539007
06429810539014
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIb
Class I
Class IIa
Special Device Type
Software
-1192
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
FI-MF-000002451

Other devices from DigiFinland Oy

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