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