Gambro Artis 230V Physio Plus Dialysis System - HSA Registration DE0503803
Access comprehensive regulatory information for Gambro Artis 230V Physio Plus Dialysis System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503803 and owned by Gambro Dasco S.P.A. The device was registered on November 08, 2019.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
The Artis Dialysis System is intended to perform intermittent Hemodialysis (HD), Hemofiltration (HF) and Hemodiafiltration (HDF) therapies. The Artis Dialysis System is intended to treat patients with chronic or acute renal failure upon prescription by a physician. The Artis Dialysis System is intended to be used by trained operators in chronic dialysis facilities and Limited Care Centers. The Artis Dialysis System is designed to control and supervise the extracorporeal circuit. To prevent blood coagulation, heparin may be infused through a Heparin delivery system. Moreover, the system produces dialysis, substitution and infusion fluids at a desired temperature, conductivity and pressure within given specifications, and supervises the delivery of fluids. The Artis Dialysis System is designed and validated to support the Gambro BiCart Cartridge and the Gambro BiCart Select system (i.e. the SelectCart cartridge and SelectBag One or SelectBag Citrate container concentrate).