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VistaSoft Trace

by Audax d.o.o. Slovenia EUDAMED

Ref 3

EMDN Z119092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number383008321CEPH5Z Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Various bioimaging and radiotherapy instruments - Medical device software
Model / Reference
3
Primary DI / UDI-DI
03830083213007
Basic UDI-DI
383008321CEPH5Z
Direct Marketing DI
03830083213007
EMDN Code
Z119092 Various bioimaging and radiotherapy instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Slovenia

Manufacturer details

EUDAMED SRN
SI-MF-000030083

Other devices from Audax D.O.O.

Properties & raw data

Show properties, registry sources and raw records
  • Measuring Function
Other properties (12)
  • 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
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED ae31806e-6c12-4748-abc5-15ee16b409c1 61 fields · synced 23 Oct 2026