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Simply evo

by IBIS Srl Italy EUDAMED

Ref 01.15.016.001

EMDN Z11039016

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number803404167MOBILEUNU3 Basic UDI-DIDate6 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Mobile X-Ray Units
Model / Reference
01.15.016.001
Primary DI / UDI-DI
08034041670047
Basic UDI-DI
803404167MOBILEUNU3
Direct Marketing DI
08034041670047
EMDN Code
Z11039016 Mobile radiographic units
Device Class
Class IIb
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000024698

Other devices from IBIS Srl

See all devices from IBIS Srl →

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 9dffb931-a5c9-4698-8b82-afb82767fe90 61 fields · synced 22 Oct 2026