Regulatory & legal information

FlowSens® injector is made to inject contrast media and saline solution for the CT exam.

monoFlow® and manyFlow® devices are filling and injection systems for contrast media and saline in CT scanner.

secufill® is a patient line with double level safety valve for all CT and MRI injectors.

These medical devices are intended for use by medical imaging and diagnostic healthcare professionals.

For complete information about precautions and optimal usage conditions for these medical devices, we recommend consulting the instructions notices/user’s manuals.

Class: 

  • FlowSens® : IIb.
  • monoFlow® and manyFlow® : IIa.
  • secufill® : IIa.

These products are medical devices which are EC marked according to the regulatory requirements.

CE Certificate: in compliance with directive 93/42/EEC.

Notified body: LNE G-Med (CE 0459).

Complying with European Directive ROHS 2011/65/UE.

Manufacturer: MEDEX
240 allée Jacques Monod
69800 Saint-Priest - France

Last update: April, 2015