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by Tietoevry Sweden AB Sweden EUDAMED

Ref 133455

EMDN Z12040192

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number643007665AACEB Basic UDI-DIDate8 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
133455
Primary DI / UDI-DI
06430076650207
Basic UDI-DI
643007665AACEB
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class IIb
Special Device Type
Software
Market of Registration
Sweden

Manufacturer details

EUDAMED SRN
SE-MF-000037728

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 937f3981-8680-4be8-8313-4b554b7bfdad 61 fields · synced 22 Oct 2026