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
The Sensor Applicator is intended to be used as part of the Continuous Glucose Monitoring (CGM) System. The System is intended for the continuous monitoring of interstitial fluid glucose levels in patients 3 years and older with diabetes mellitus type 1 or 2. The System is also intended to replace fingerstick testing for diabetes treatment decisions, including dosing of insulin.