DEVICE DETAILS
NAME OF DEVICE | CHILINE PULSE OXIMETER (WITH OR WITHOUT RESPIRATORY MONITORING) (S68/S68 LITE) |
---|---|
ESTABLISHMENT NAME | SCIENCE VALLEY RETES SDN. BHD. |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GC8953224-172914 |
BRAND NAME | CHILINE |
MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | Chiline Pulse Oximeter (with or without Respiratory Monitoring) is a pulse oximeter, which can measure blood oxygen level (SpO2) via optical sensor and can be divided in 2 models including S68 and S68 Lite. This product uses optical sensor, a non-invasive technology that is suitable for adults, children and infants. Upon recommendations from their physicians, users can operate this product on their own to measure single or continuous blood oxygen level, heart rate and respiratory rate (S68 Lite does not have respiratory rate measurement feature). The results will be displayed in a mobile App, serving as a reference for physicians for diagnosis. |
DEVICE INTENDED PURPOSE | S68 is to measure the oxygen level (oxygen saturation) of the blood, heart rate and respiration. And S68 Lite is only to measure oxygen level of the blood and heart rate. |
VALIDITY DATE OF REGISTRATION | 27/05/2024 - 26/05/2029 |