DEVICE DETAILS
| NAME OF DEVICE | CHILINE PULSE OXIMETER MONITORING SYSTEM (WITH OR WITHOUT MONITORING RESPIRATION) |
|---|---|
| ESTABLISHMENT NAME | WELLSPRING SOLUTIONS SDN. BHD. |
| ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
| REGISTRATION NO | GC6331224-177056 |
| BRAND NAME | CHILINE/ S68 AND S68 LITE |
| MEDICAL DEVICE CATEGORY | MD 1100 - GENERAL ACTIVE MEDICAL DEVICES |
| DEVICE GROUPING TYPE | FAMILY |
| DEVICE DESCRIPTION | This product is a monitoring system for blood oxygen level and respiration. It can simultaneously measure blood oxygen level (SpO2), heart rate and respiratory rate, and can record and display results. |
| DEVICE INTENDED PURPOSE | 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. The results will be displayed in a mobile App, serving as a reference for physicians for diagnosis. Note: Model S68 Lite does not have a respiratory monitoring feature. |
| VALIDITY DATE OF REGISTRATION | 20/07/2024 - 19/07/2029 |