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BoneXpert

by Visiana ApS Denmark EUDAMED

Ref 3.2

EMDN Z11069092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-574400661BONEXPERTH94K Basic UDI-DIDate18 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
3.2
Primary DI / UDI-DI
D-574400661BONEXPERTH94K
Basic UDI-DI
B-574400661BONEXPERTH94K
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
Device Class
Class I
Special Device Type
-1192
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
DK-MF-000029049

Other devices from Visiana ApS

  • BoneXpert

    Class II

Properties & raw data

Show properties, registry sources and raw records
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

Sources (1)

  • EUDAMED 0dd1e262-c1bf-4f98-b06a-a19cb4516874 61 fields · synced 23 Oct 2026