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DEVICE DETAILS

NAME OF DEVICECHILINE PULSE OXIMETER (WITH OR WITHOUT RESPIRATORY MONITORING) (S68/S68 LITE)
ESTABLISHMENT NAMESCIENCE VALLEY RETES SDN. BHD.
ROLE OF ESTABLISHMENTAUTHORIZED REPRESENTATIVE
REGISTRATION NOGC8953224-172914
BRAND NAMECHILINE
MEDICAL DEVICE CATEGORYMD 1302 - Monitoring devices of vital physiological parameters
DEVICE GROUPING TYPEFAMILY
DEVICE DESCRIPTIONChiline 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 PURPOSES68 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 REGISTRATION27/05/2024 - 26/05/2029

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1L-Size SpO2 Probe PA68
2M-Size SpO2 ProbePM68
3S-Size SpO2 Probe PC68
4XS-Size SpO2 ProbePB68
5Ring SpO2 ProbePR68
6Chiline Pulse Oximeter Monitoring System (with or without Monitoring Respiration)S68
7Chiline Pulse Oximeter Monitoring System (with or without Monitoring Respiration)S68Lite
8Storage caseN/A
9Charging cableN/A
10Protective coverN/A
11Instruction manualN/A
12L-Size SpO2 Probe PA68
13M-Size SpO2 ProbePM68
14S-Size SpO2 Probe PC68
15XS-Size SpO2 ProbePB68
16Ring SpO2 ProbePR68
17Chiline HomeCare AppVersion: V3