HSA · registration DE0510484GE Portrait Mobile Monitoring Solution
- Registration number
- DE0510484
- Model name
- PORTRAIT SBT01; Portrait CAU01; PORTRAIT SpO2 P-SA01; PORTRAIT RR P-RR01; PORTRAIT SpO2 P-SP01; Portrait HSWXB; Portrait HSWXB; Portrait CVAXB; Portrait CVAXB ; Portrait HUBXB; Portrait Core Services CSSXB; Portrait Core Services CSSXB
- Model identifier
- 2096442-001; 2102549-001; 2103502-001; 2103567-001; 2104045-001; 5700219-11; 5700672-12; 5863721-11; 5863721-12; 5923524; 5933539; 5973340
- Registration date
- March 20, 2025
- Source update date
- May 08, 2026
- Risk class
- Class C
- Product owner
- GE Healthcare Finland Oy
- Registrant / registration holder
- GE HEALTHCARE TECHNOLOGIES PACIFIC PRIVATE LIMITED
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.
- Product owner address
- Kuortaneenkatu 2, FI-00510 Helsinki, Finland
- Registrant address
- 11 North Buona Vista Drive, #11-07, The Metropolis, Singapore 138589
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.