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03-4000-00

by ASG Superconductors S.p.A. Italy EUDAMED

Ref 03-4000-00 V1Model MRopen EVO EMDN Z11050102

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++B545034000ZK Basic UDI-DIDate13 May 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  • Withdrawn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 22 Oct 2026

Device Name
03-4000-00
Model / Reference
MRopen EVO, 03-4000-00 V1
Primary DI / UDI-DI
+B5450340000010
Basic UDI-DI
++B545034000ZK
Direct Marketing DI
+B5450340000010
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 cf9f3862-e5c0-43c7-ad79-101897c0ec83 61 fields · synced 22 Oct 2026