Pulsion PulsioFlex - HSA Registration DE0015941
Access comprehensive regulatory information for Pulsion PulsioFlex in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0015941 and owned by Pulsion Medical Systems SE. The device was registered on July 11, 2014.
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 use of the PulsioFlex is indicated in at risk patients undergoing surgical interventions where cardiovascular monitoring is necessary. It is indicated in patients in Recovery Rooms/Step Down Units, High Dependency/Intermediate Care Units, A&E/Emergency Departments, Surgical, Medical, Burn, Trauma and other units/areas where blood pressure and/or cardiac output trend monitoring is necessary (ProAQT). Continuous monitoring of central venous oxygen saturation (CeVOX) is indicated in all intensive care patients particularly in cases of sepsis and multi-organ failure; management of early goal directed therapy in severe sepsis; Cardiogenic Shock and Cardiopulmonary Resuscitation. The Indocyanine Green concentration and elimination measurement is indicated in all patients with persistent or expected limitations of their global liver function (cellular function or perfusion) and/or splanchnic perfusion (LiMON).