Sinocare's Full CGM Product Line 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 Second-Generation Continuous Glucose Monitoring (CGM) System has obtained certification under the European Union Medical Device Regulation (EU) 2017/745 (MDR). As one of the most stringent regulatory frameworks in the world, CE-MDR certification signifies that the product meets internationally recognized standards for safety and performance. It also highlights Sinocare’s strong capabilities in CGM R&D and regulatory compliance, laying a solid foundation for further global market expansion.

The newly approved second-generation CGM features easy application, a compact and lightweight design, and reliable accuracy. It is approved for use in individuals aged 2 years and above, providing real-time glucose monitoring through interstitial fluid, without the need for finger pricks, and enabling continuous monitoring for up to 15 days. Built with Sinocare’s proprietary third-generation glucose sensor technology, the system offers strong anti-interference capabilities, delivering precise data to support informed diabetes treatment decisions.

A key advancement in this generation is the all-in-one structural design, which requires no assembly and allows for one-click application, significantly improving user comfort and convenience—especially for children, the elderly, and users with limited dexterity.

Following Sinocare’s milestone achievement in 2023 as the first Chinese CGM brand to obtain CE-MDR certification, this second-generation approval further reinforces the company’s commitment to continuous innovation in the CGM field. As the product expands into key global markets including the EU and the United States, Sinocare is poised to strengthen its leadership in the global glucose monitoring sector.

With a focus on delivering high-standard diabetes management solutions worldwide—especially for young children living with diabetes—Sinocare continues to advance innovative technologies in pursuit of a healthier and sweeter future.