Core Viewpoint - The approval of the Gems embryo culture medium series (VitBase embryo processing fluid) 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: Product Approval and Significance - The Gems embryo culture medium series received its Class III medical device registration certificate on August 25, 2025, indicating regulatory support for the innovation and transformation of overseas-acquired medical products [1] - VitBase embryo processing fluid is the first of 11 products in the GEMS series to receive medical device approval, paving the way for the subsequent domestic production of the entire product line in China [2] Group 2: Market Context and Impact - Historically, core culture media used in IVF laboratories in China have relied heavily on overseas brands, making the safety, stability, and long-term clinical validation of these products critical for both doctors and patients [1] - The approval of VitBase embryo processing fluid, developed from over 30 years of clinical experience by Genea Biomedx, enhances product accessibility and supply chain security while maintaining international quality standards [1]
贝康医疗(02170.HK)：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