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Pixium Static

by Thales Avs France SAS FDA registration: France EUDAMED

Ref PIXIUM PORTABLE 4343 EZ-C HD EMDN Z11031101

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number37014401082K Basic UDI-DIDate11 Mar 2024RegisteredStatusActive

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  • Withdrawn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

Device Name
Pixium Portable Ez Hd
Model / Reference
PIXIUM PORTABLE 4343 EZ-C HD
Primary DI / UDI-DI
03701440100349
Basic UDI-DI
37014401082K
EMDN Code
Z11031101 Multifunctional systems for direct digital radiology
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000012704

Related devices

Category: Stationary basic diagnostic x-ray system, digital

Other devices from Thales Avs France SAS

See all devices from Thales Avs France SAS →

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 9e353f1e-14ab-4946-9ab9-c0185500c9c9 61 fields · synced 24 Oct 2026