Core Insights - The company, Beikang Medical-B (02170), announced that its Gems embryo culture medium series (VitBase embryo processing fluid) received a Class III medical device registration certificate from the National Medical Products Administration (NMPA) on August 25, 2025 [1] - This approval highlights the support from the government for the innovative transformation of medical products acquired overseas, positioning the company as one of the few globally to hold CE, FDA, and TGA certifications for assisted reproductive fluids [1] - The VitBase embryo processing fluid is the first of 11 products in the GEMS embryo culture medium series to receive medical device approval, marking a significant step towards the localization of high-quality embryo culture technology in China [2] Company Overview - The Gems embryo culture medium series is developed by Genea Biomedx Pty Ltd., a wholly-owned subsidiary of BMX Holdco Pte. Ltd., which is fully owned by the company [1] - The approval of VitBase embryo processing fluid is based on over 30 years of clinical experience from Genea Biomedx, ensuring high product quality while enhancing accessibility and supply chain security [1] Industry Context - 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 successful registration of the VitBase embryo processing fluid lays the groundwork for the subsequent localization of the entire product line in China [2]
贝康医疗-B(02170)：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