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Dynamic X-Ray

by Dinamik Rontgen Sanayi ve Ticaret Limited Sirketi EUDAMED

Active European Union

Ref SIP3Model PROFILE D 50 R

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number869891891SIP3ZU Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
PROFILE D 50 R, SIP3
Primary DI / UDI-DI
08698918916524
Basic UDI-DI
869891891SIP3ZU
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
Device Class
Class IIb
Medical Purpose
The system is intended to combine compatible CE-marked medical devices and accessories to perform diagnostic X-ray imaging of the human body by qualified healthcare professionals in healthcare facilities.

Manufacturer details

EUDAMED SRN
TR-PR-000044023

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Properties

Other properties (1)

  • Sterile: No