DEVICE DETAILS
NAME OF DEVICE | PULSE OXIMETER |
---|---|
ESTABLISHMENT NAME | KINSMEDIC SDN BHD |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GC7817621-66828 |
BRAND NAME | BEURER PULSE OXIMETER |
MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | Beurer Pulse Oximeter is used to measure oxygen saturation. Oxygen saturation indicates the percentage of haemoglobin in arterial blood that is loaded with oxygen. Therefore it is an important parameter for assessing the respiratory function. A low oxygen saturation value generally indicates underlying illnesses (respiratory diseases, asthma, heart failure etc.). |
DEVICE INTENDED PURPOSE | Only use the Beurer pulse oximeter on humans to measure the arterial oxygen saturation (SpO₂) of haemoglobin, the perfusion index (PI) and the heart rate (pulse rate). The pulse oximeter is suitable for private use (at home) as well as for use in the medical sector (hospitals, medical establishments). |
VALIDITY DATE OF REGISTRATION | 05/07/2021 - 04/07/2026 |