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MEDRAD® Salient MEDRAD® Vistron Plus Contrast Injection System

by Imaxeon Pty Ltd 13 variants

Ref ZY6322

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number934539000TFCN-0103UW Basic UDI-DI 09345390002861UDI-DIDate9 Sep 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
MEDRAD® Salient MEDRAD® Vistron Plus Sterile Disposables
Model / Reference
ZY6322
Primary DI / UDI-DI
09345390002861
Basic UDI-DI
934539000TFCN-0103UW
EMDN Code
A02010401 Syringes for contrast media injector, single-use
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
AU-MF-000009702
Authorised representative
Bayer Medical Care B.V. NL-AR-000000240

Other devices from Imaxeon Pty Ltd

See all devices from Imaxeon Pty Ltd →

Properties

  • Sterile

Other properties (12)

  • 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