Sinocare iCan CGM Receives CE-MDR Certification, Approved for Use in People with Diabetes Aged 2 and Above

Recently, Sinocare Inc. (Stock Code: 300298) announced that its independently developed “Sinocare iCan Continuous Glucose Monitoring (CGM) System” has been officially certified under the European Medical Devices Regulation (EU) 2017/745 (MDR). As one of the world’s most rigorous regulatory frameworks, CE-MDR certification signifies that the product meets international standards for safety and effectiveness. This milestone further highlights Sinocare’s strong capabilities in CGM research and development, as well as regulatory compliance, laying a solid foundation for the product’s global expansion.

The newly approved next-generation CGM features easy application, a lightweight and compact design, and high accuracy and stability. It is approved for continuous glucose monitoring in individuals aged 2 and above, using interstitial fluid without the need for finger pricks, and supports 15 days of continuous monitoring. Powered by Sinocare’s proprietary third-generation glucose sensor technology, the device offers strong anti-interference performance, enabling more precise data to support diabetes treatment decisions. A key innovation is its all-in-one integrated structure, which eliminates assembly—simply press to apply—enhancing comfort and ease of use, especially for children and the elderly.

In September 2023, Sinocare became the first Chinese CGM brand to receive CE-MDR certification, marking its alignment with top-tier international standards in glucose sensing technology. As a global leader in digital diabetes management, Sinocare is not only advancing innovation to meet international benchmarks, but also actively fulfilling its social responsibilities. Since 2023, the company has continuously carried out CGM trial programs and public diabetes education campaigns, aiming to raise awareness and promote the concept of “early detection, early intervention.”

The CE-MDR approval of this new-generation CGM product is expected to further strengthen Sinocare’s leadership in global glucose monitoring. The company remains committed to delivering high-standard glucose management tools worldwide—with a particular focus on supporting the healthy growth of young people with diabetes, and leading the future of precision diabetes care.