LEGAL NOTICE
The S³ monitor and associated disposables are designed for use in frequent haemodialysis for the treatment of chronic renal failure. These medical devices are regulated health products that bear, under this regulation, the CE marking in accordance with Directive 93/42 / EEC & 2007/47 / EC. Read the instructions for use provided with the products carefully before use.
Monitor S³, S³.PHYSI.SBAN: Class IIb medical devices; certification body CE0459 / LNE GMED.
Manufacturer: PHYSIDIA, 11/13 Bd des Bretonnières – 49124 Saint-Barthélémy.
S³.PHYSI.FLOW-150 and S³ PHYSIFLOW ERGO : Class IIa medical devices; certification body CE0459 / LNE GMED.
Manufacturer : PHYSIDIA, 11/13 Bd des Bretonnières – 49124 Saint-Barthélémy.
Blood line S³.PHYSI.LINE: Class IIa medical devices; certification body CE0123 / TÜV SÜD.
Manufacturer: F.M. S.p.A Via Farini 65 bis 13043 Cigliano (VC) Italie.
Dialysate bags HMB35/1,5 and HML40/1,5: Class IIb medical devices; certification body – CE0123 / TÜV SÜD.
Manufacturer: HAEMOPHARM BIOFLUIDS s.r.l Via dell’Industria 6, I – 23030 Tovo S. Agata (S.O) Italy.
S³ is a registered trademark of Physidia SA