Fysicon QMAPP Hemodynamic Monitoring Solutions - HSA Registration DE0505512
Access comprehensive regulatory information for Fysicon QMAPP Hemodynamic Monitoring Solutions in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505512 and owned by Fysicon B.V.. The device was registered on March 01, 2021.
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.
QMAPP is intended to be used for acquiring, filtering, digitizing, amplifying, measuring and calculating, displaying, recording and monitoring of clinical data from adult and pediatric patients. Clinical data includes: ECG waveforms, heart rate, pulse oximetry (SpO2), respiration rate, EtCO2, temperature, hemodynamic measurements like; valve gradients and areas; cardiac output; shunts; Fractional Flow Reserve (FFR); invasive and non invasive blood pressure. Physiological parameters such as diastolic, systolic, and mean pressures, and heart rate are derived from the signal data, displayed and recorded. Data is entered manually or acquired via interfaced devices and/or information systems and may be used for report generation. QMAPP can be used in hospital and clinical settings including interventional laboratories (e.g. electrophysiology and cardiac catheterization), operating room environments, pre and post areas all under the direct supervision of licensed healthcare practitioners.