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MEDRAD® Salient Contrast Injection System

by Imaxeon Pty Ltd Australia EUDAMED

Ref DC009SW EMDN Z11039013

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number934539000TFCN-0102UU Basic UDI-DIDate14 May 2026RegisteredStatusActive

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  • Withdrawn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 25 Oct 2026

Model / Reference
DC009SW
Primary DI / UDI-DI
09345390001352, 09345390003028
Basic UDI-DI
934539000TFCN-0102UU
EMDN Code
Z11039013 Angiographic injectors
Device Class
Class IIb
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 & raw data

Show properties, registry sources and raw records
  • Administering Medicine
Other properties (12)
  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 1e43d474-6806-4836-9469-e2daa9ffb715 61 fields · synced 25 Oct 2026
  • EUDAMED 09345390003028|934539000TFCN-0102UU 61 fields · synced 15 Jul 2026