Core Viewpoint - The approval of Geri embryo culture medium by the National Medical Products Administration (NMPA) in China marks a significant milestone for the company, enabling it to address the challenges faced by older patients in embryo cultivation and filling a gap in the domestic high-end assisted reproductive consumables market [1][2]. Group 1 - The Geri embryo culture medium received a Class III medical device registration certificate from the NMPA on February 25, 2026 [1]. - Prior to this approval, the Geri embryo culture medium had already obtained certifications from the European Union (CE), the U.S. Food and Drug Administration (FDA), and the Australian Therapeutic Goods Administration (TGA) [1]. - The core technology of the Geri embryo culture medium is derived from the Sydney IVF Center, and it combines with the Geri wet incubator and AI embryo assessment system to enhance clinical practice in China [1]. Group 2 - The technology focuses on creating a systematic solution for fertility challenges faced by older patients, featuring a "triple antioxidant protection network" that effectively addresses oxidative stress in older embryos [2]. - The combination of the culture medium with the Geri wet incubator and AI embryo assessment system has been clinically validated to significantly improve the rates of quality blastocysts and clinical pregnancy, providing strong support for older fertility [2]. - The approval signifies a critical transition for the company from technology introduction to localized production, making it the first Chinese enterprise to hold FDA, CE, TGA, and NMPA certifications [2].
贝康医疗-B(02170.HK)：Geri胚胎培养液(Gems胚胎培养液系列产品之一)获国家药监局颁发医疗器械注册证