GE Portrait Mobile Monitoring Solution - HSA Registration DE0510484
Access comprehensive regulatory information for GE Portrait Mobile Monitoring Solution in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510484 and owned by GE Healthcare Finland Oy. The device was registered on March 20, 2025.
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 Portrait Mobile Monitoring Solution is intended to acquire, store, calculate, display and export patient monitoring data as well as provide real time alarming for monitoring adult and pediatric patients (3 years of age and older, and weighing more than 10 kg). Physiological parameters and waveforms supported are: • Pulse oximetry (SpO2/pulse rate) and • Respiration rate (RR). Continuous pulse oximetry and respiration rate monitoring may be used for patients at risk of cardiorespiratory and infectious complications. The Portrait Mobile Monitoring Solution is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The Portrait Mobile Monitoring Solution is not intended for use in a controlled Magnetic Resonance (MR) environment.