Device Dossier
Subcutaneous glucose sensor
Device Dossier for Subcutaneous glucose sensor (Subcutaneous glucose sensor, Class IIb, sponsor Emergo). ARTG record, intended purpose, GMDN category —…
- GMDN category: Subcutaneous glucose sensor
Intended purpose
When the Continuous Glucose Monitoring System Sensor is used together with compatible devices, it is intended to continuously measure the glucose in the interstitial fluid and is designed to replace fingerstick blood glucose (BG) testing for treatment decisions.