Yuwell CT3 CGM system - Invasive interstitial-fluid glucose monitoring system

Intended purpose

The CT3 Series Continuous Glucose Monitoring System (CT3 System) is a real time, contin-u ous glucose monitoring device indicated for the management of diabetes in adult (age≥18 years). Interpretation of the CT3 System results should be based on the glucose trends and several sequential readings over time. The CT3 System also aids in the detection of episodes of hyperglycemia and hypoglycemia. It is intended for single patient use. It is intended to replace fingerstick blood glucose testing for diabetes treatment decisions, unless otherwise indicated.