Gambro Prismaflex™ Haemodialysis Control Unit - HSA Registration DE0000549
Access comprehensive regulatory information for Gambro Prismaflex™ Haemodialysis Control Unit in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0000549 and owned by Gambro Lundia AB. The device was registered on May 03, 2005.
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 Prismaflex control unit is intended for: - Continuous Renal Replacement Therapy for patients with acute renal failure and/or fluid overload. - Therapeutic Plasma Exchange Therapy for patients with diseases where removal of plasma components is indicated. - Hemoperfusion for patients with conditions where immediate removal of substances by adsorption is indicated. - Hemopurification for patients with conditions where extracorporeal elimination of carbon dioxide is indicated (only applicable for SW version 8.10 and above). All treatments administered via the Prismaflex control unit must be prescribed by a physician.