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Diana

by Ropca A/S Denmark EUDAMED

Ref D1

EMDN Z11049092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number57000022093D1PN Basic UDI-DIDate26 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Diana
Model / Reference
D1
Primary DI / UDI-DI
05700002209313
Basic UDI-DI
57000022093D1PN
Direct Marketing DI
05700002209313
EMDN Code
Z11049092 Various ultrasound instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000011938

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 3a08e3f0-bd74-4c18-9133-f2ca11245ad5 61 fields · synced 22 Oct 2026