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x-ray insights

by dentalXrai GmbH EUDAMED

Active European Union

Ref v3.0

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-dentalXrai-Pro-v3.0X4 Basic UDI-DIDate7 Nov 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
dentalXrai Pro
Model / Reference
v3.0
Primary DI / UDI-DI
D-dentalXrai-Pro-v3.0X4
Basic UDI-DI
B-dentalXrai-Pro-v3.0X4
EMDN Code
V92 Medical device software - not included in other classes
Device Class
Class I
Special Device Type
-1192
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000005732

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