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Vitaly Questionnaires

by Open Line Vitaly d.o.o. EUDAMED

Active European Union

Ref 1.0.0.Model 1.0.0

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-03830088640013 Basic UDI-DIDate6 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
1.0.0, 1.0.0.
Primary DI / UDI-DI
03830088640013
Basic UDI-DI
B-03830088640013
EMDN Code
Z12040192 General medicine diagnosis and monitoring instruments - medical device software
Device Class
Class I
Market of Registration
Slovenia

Manufacturer details

EUDAMED SRN
SI-MF-000002597

Properties

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No