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The future ofcontinuous blood glucose monitoring is now.

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Stockstädter Str. 17, 63762 Großostheim, DE

Stockstädter Str. 17, 63762 Großostheim, DE

+49 (0) 6026 942 0

+49 (0) 6026 942 0

+49 (0) 6026 942 126

+49 (0) 6026 942 126

info@FiberSense-cxm.com

info@fibersense-cxm.com

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The FiberSense CGM System is a CE-marked Class IIb medical device under Regulation (EU) 2017/745. It is intended as a continuous glucose monitoring system for home-use continuous measurement in adults with diabetes. The system measures glucose concentrations in tissue fluid and supports the monitoring of blood sugar levels and glucose trends as part of diabetes self-management. The FiberSense CGM System should be used only as described in the Instructions for Use. Contraindications, warnings, precautions, calibration requirements, smartphone compatibility requirements, protection ratings and other limitations apply. The system is not intended for use in children or adolescents under 18 years of age or during pregnancy. Users should consult their healthcare professional regarding individual diabetes management decisions and should use a blood glucose meter where required by the Instructions for Use. Therapeutic decisions remain the responsibility of the user and/or healthcare professional and should be made in accordance with the Instructions for Use, clinical guidance and blood glucose meter readings where required. The FiberSense App is designed as part of the FiberSense CGM System and does not provide autonomous diagnosis, therapy recommendations or automated treatment control. The sensor is designed to be worn for up to 28 days. When properly attached to the sensor, the detector and base plate form a protected connection; the applicable protection rating is described in the Instructions for Use. Clinical and performance data supporting the intended use, wear period and product claims are available upon request where appropriate, including study design, study population, endpoints, comparator information, accuracy metrics and limitations.

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