DEVICE DETAILS
NAME OF DEVICE | NOVOTEMP MULTI-FUNCTION INFRARED THERMOMETER |
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ESTABLISHMENT NAME | REVO HEALTHCARE SDN BHD |
ROLE OF ESTABLISHMENT | AUTHORIZED REPRESENTATIVE |
REGISTRATION NO | GB6128319-26799 |
BRAND NAME | NOVOTEMP |
MEDICAL DEVICE CATEGORY | MD 1302 - Monitoring devices of vital physiological parameters |
DEVICE GROUPING TYPE | FAMILY |
DEVICE DESCRIPTION | The TH50Z and TH520 Infrared Thermometer allows measurement of body temperature. The temperature is taken between the forehead and the temple or alternatively in the ear. The reading is displayed within a few seconds. Apart from measuring body temperature, the TH50Z and TH520 Infrared Thermometer can also be used to measure the temperature of objects (e.g. fluids, surfaces, ambient temperature). The temperature range for this function is between -22°C and 80°C. The reading recorded is displayed within seconds. |
DEVICE INTENDED PURPOSE | The TH50Z and TH520 Infrared Thermometer is intended for the intermittent measurement and monitoring of human body temperature by carrying out measurement in the ear or on the central forehead. Additionally, the thermometer is suitable to measure the temperat ure of objects in the range of -22°C to 80°C (-7.6°F - 176°F). |
VALIDITY DATE OF REGISTRATION | 13/03/2019 - 12/03/2024 |