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X-DRS Mobile Elite

by EXAMION GmbH Germany EUDAMED

Ref SY.000130Model X-DRS Mobile Elite EMDN Z11039016

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number14066353EXMobileXRaySys3V Basic UDI-DIDate2 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
X-DRS Mobile Elite, SY.000130
Primary DI / UDI-DI
04066353008007
Basic UDI-DI
14066353EXMobileXRaySys3V, 4066353EXMobileXRaySysXD
EMDN Code
Z11039016 Mobile radiographic units
Device Class
Class IIb
Medical Purpose
The mobile X-ray unit is a device for general radiography in hospitals, clinics, radiology imaging centers, and medical practices. It is suitable for diagnostic X-ray imaging of the skull, spine, chest, abdomen, extremities, and other body parts in intensive care units, emergency departments, radiology departments, and medical practices. The system is not suitable for mammography.

Manufacturer details

EUDAMED SRN
DE-PR-000019918

Other devices from EXAMION GmbH

Properties & raw data

Show properties, registry sources and raw records
Other properties (1)
  • Sterile: No

Sources (2)

  • EUDAMED 9efad79f-2d88-448d-83aa-e0af4afccbed 61 fields · synced 25 Oct 2026
  • EUDAMED 04066353008007|4066353EXMOBILEXRAYSYSXD 61 fields · synced 25 Oct 2026