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X-DRS Ceiling Flow

by EXAMION GmbH Germany EUDAMED

Ref SY.000131Model X-DRS Ceiling Flow EMDN Z11039005

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number14066353EXXRayDigiSysJD 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  • Withdrawn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 24 Oct 2026

Model / Reference
X-DRS Ceiling Flow, SY.000131
Primary DI / UDI-DI
04066353008014
Basic UDI-DI
14066353EXXRayDigiSysJD, 4066353EXXRayDigiSysJC
EMDN Code
Z11039005 Radiogenic complexes
Device Class
Class IIb
Medical Purpose
Intended for use by qualified personnel only, as radiology technicians and doctors who have licenses in the radiology field, on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Neither for mammography nor for chest survey. This X-ray System is designed for general radiography in hospitals, clinics, radiology imaging centers and medical practices.
Intended for use by qualified personnel only, as radiology technicians and doctors who have licenses in the radiology field, on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Neither for mammography nor for chest examination. This X-ray system is designed for general radiography in hospitals, clinics, radiology imaging centers and medical practices.

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 ab27d766-8a29-4b43-9b14-eb401ed884f7 61 fields · synced 22 Oct 2026
  • EUDAMED 04066353008014|4066353EXXRAYDIGISYSJC 61 fields · synced 24 Oct 2026