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三诺生物:公司第二代CGM产品于2025年7月获得欧盟MDR认证
Mei Ri Jing Ji Xin Wen· 2025-08-11 13:56
Core Viewpoint - The company has withdrawn its application for the first-generation continuous glucose monitoring (CGM) product and is focusing on the second-generation product, which is expected to receive necessary certifications in the coming years [2] Group 1 - The second-generation CGM product is anticipated to obtain the Class III medical device registration certificate from the National Medical Products Administration (NMPA) by December 2024 [2] - The company expects to achieve European Union Medical Device Regulation (MDR) certification for the second-generation product by July 2025 [2] - The timeline for submitting the new CGM product registration application to the U.S. FDA will depend on the feedback from the FDA and the completion of necessary trials [2]