Declaration Of Conformity

EU Declaration of Conformity in accordance with Radio Equipment

Directive (RED) 2014/53/EU

Eversense CGM System Smart Transmitter Download

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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-info.

The Eversense®XL Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 180 days. It is intended to complement, not replace, fingerstick blood glucose monitoring. The sensor insertion and removal procedures are performed by a health care provider. The Eversense XL CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see global.eversensediabetes.com/safety-info.