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MROpen Evo

by ASG Superconductors S.p.A. Italy EUDAMED

Ref 03-2000-00 V12Model 03-2000-00

EMDN Z11050102

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B545032000Z5 Basic UDI-DIDate15 Dec 2023RegisteredStatusActive

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
Mr Open Evo
Model / Reference
03-2000-00, 03-2000-00 V12
Primary DI / UDI-DI
+B54503200000120
Basic UDI-DI
++B545032000Z5
Direct Marketing DI
+B54503200000120
EMDN Code
Z11050102 Open magnet MRI scanners with magnetic field intensity less than or equal to 0.5t
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000029567

Other devices from ASG Superconductors S.p.A.

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 6baf3fad-4834-4845-8ff6-16609540fa26 61 fields · synced 22 Oct 2026