Core Viewpoint - The approval of the Gems embryo culture medium series (VitBase embryo processing solution) by the National Medical Products Administration marks a significant milestone for the company, establishing it as one of the few global enterprises with CE, FDA, and TGA certifications in the assisted reproductive technology sector [1][2]. Group 1 - The Gems embryo culture medium series is developed by Genea Biomedx, a wholly-owned subsidiary of BMX Holdco Pte. Ltd., and received its Class III medical device registration certificate on August 25, 2025 [1]. - The approval reflects the support from the national government for the innovative transformation of medical products acquired from overseas [1]. - The VitBase embryo processing solution is based on over 30 years of clinical experience from Genea Biomedx, ensuring high product quality while enhancing accessibility and supply chain security [1]. Group 2 - VitBase is the first of 11 products in the GEMS embryo culture medium series to receive medical device approval, indicating a gradual localization of international first-class culture medium technology [2]. - This approval lays the foundation for the subsequent domestic production of the entire series of culture media in China [2].
贝康医疗-B：Gems胚胎培养液系列(VitBase胚胎处理液)获国家药监局颁发医疗器械注册证