Declaration of Conformity

EU Declaration of Conformity in accordance with Radio Equipment

Directive (RED) 2014/53/EU

Eversense 365 and E3 CGM System Smart Transmitter

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MKT-001538 Rev 4

The Eversense® E3 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to 180 days in persons with diabetes age 18 and older. The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration primarily one time a day after day 21, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense E3 CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see https://global.eversensediabetes.com/safety-information/.
The Eversense® 365 Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels for up to one year in people (18 years and older) with diabetes. The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are required for calibration one time a week after day 13, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense 365 CGM System is a prescription device; patients should talk to their health care provider to learn more.  For important safety information, see https://global.eversensediabetes.com/safety-information/