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Friska Kliniska Beslutsstöd (Friska CDSS)

by Friska AB

Ref Friska CDSS

Active European Union

CE MDR

Valid until

9 Jul 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Kiwa Assurance B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberP000532877CRT02 Date20 Oct 2026IssuedStatusActive expires 9 Jul 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • P000532877CRT02 Active Amended

    Quality management system EU MDR

    Certifier
    Kiwa Assurance B.V. 1912
    Issued
    20 Oct 2026
    Expires
    9 Jul 2031
    Reason
    Mnf data change

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Friska Clinical Decision Support System (Friska CDSS)
Model / Reference
Friska CDSS
Primary DI / UDI-DI
17350152580029
Basic UDI-DI
735015258HEALTH001YQ
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class IIa
Special Device Type
Software
EU market of registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000045973

Other devices from Friska 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