Device Dossier
Thermometer, infrared, skin
Device Dossier for Thermometer, infrared, skin (Thermometer, infrared, skin, Class IIa, sponsor Exactus Instruments). ARTG record, intended purpose, GMDN…
- GMDN category: Thermometer, infrared, skin
Intended purpose
The device is intended for the non-invasive measurement of human body temperature using infrared sensing technology, specifically designed to detect thermal radiation emitted from the skin surface at the forehead and the ear canal. Embedded within the device is an integrated electronic chip containing software algorithms programmed to accurately convert detected infrared signals into temperature readings, precisely calibrated to correspond to normal human physiological temperature ranges. The thermometer operates via infrared detection, thereby avoiding interference from strong ambient light and ensuring reliable, rapid temperature measurement without physical contact. It provides reference data to assist in clinical assessment, screening, and monitoring of body temperature changes.