贝康医疗-B：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

Core Insights - The company has received a Class III medical device registration certificate for its Geri embryo culture medium from the National Medical Products Administration of China, marking a significant milestone in its product development [1] - The Geri embryo culture medium has already obtained certifications from CE, FDA, and TGA, indicating its international compliance and readiness for clinical use [1][2] - The product addresses the challenges faced by older patients in embryo cultivation through its antioxidant formula and stable osmotic pressure environment, enhancing clinical pregnancy rates [2] Product Development - The Geri embryo culture medium is designed specifically to tackle fertility issues in older patients, featuring a "triple antioxidant protection network" that mitigates oxidative stress in older embryos [2] - The inclusion of human serum albumin and long-term stability simplifies laboratory operations and ensures a stable cultivation environment [2] - International clinical validation shows that the combination of Geri embryo culture medium with the Geri wet incubator and AI embryo assessment system significantly improves the quality blastocyst rate and clinical pregnancy rate [2] Market Position - The approval of the Geri embryo culture medium signifies the company's transition from technology introduction to localized production, filling a gap in the domestic high-end assisted reproductive consumables market [2] - The company is the first in China to hold FDA, CE, TGA, and NMPA certifications, establishing a strong competitive position in the industry [2] - With core PGT technology and self-supply capabilities, the company has covered most PGT licensed institutions nationwide and established numerous localized laboratories, creating a sustainable ecological barrier [2]