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.
- 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.
240 allée Jacques Monod
69800 Saint-Priest - France
Last update: April, 2015
For the manyFlow® range: Multi-use system/Use during a maximum period of 8 hours, with a new secxufill® patient line for each patient/Ensure that injection from multidose containers and more than one patient respects the valid rules of good practice and the Marketing authorization (MA) of contrast agent.
These medical devices are distributed only to multi-use markets.