BASECARE-B: Gems embryo culture medium series (VitBase embryo handling solution) has received medical device registration certificate from the National Medical Products Administration
BASECARE-B announced that its Gems embryo culture medium series (VitBase embryo handling solution) received the Class III medical device registration certificate issued by the National Medical Products Administration on August 25, 2025. This approval marks the company as one of the few assisted reproductive liquid enterprises globally to hold CE, FDA, and TGA certifications, enhancing product accessibility and supply chain security, and promoting the localization process of core culture media in domestic IVF laboratories
According to the Zhitong Finance APP, BASECARE-B (02170) announced that the company's Gems embryo culture medium series (VitBase embryo processing solution) received a Class III medical device registration certificate issued by the National Medical Products Administration (NMPA) on August 25, 2025 (Registration No.: Guo Xie Zhu Jin 20253180356).
The Gems embryo culture medium series (VitBase embryo processing solution) is developed by Genea Biomedx Pty Ltd. (Genea Biomedx), a wholly-owned subsidiary of BMX Holdco Pte. Ltd., which is fully owned by the company. This approval not only reflects the national support for the innovative transformation of medical products acquired overseas but also makes the company one of the few in the world to simultaneously hold CE, FDA, and TGA certifications for assisted reproductive liquids, with a product line covering the entire process of assisted reproduction.
For a long time, the core culture media used in IVF laboratories in China have mainly relied on overseas brands. As one of the key factors affecting the success rate of in vitro fertilization, the safety, stability, and long-term clinical validation data of culture media are crucial for both doctors and patients. The VitBase embryo processing solution approved this time is derived from Genea Biomedx's over 30 years of clinical experience, combined with localized production and regulatory requirements, which not only maintains the international high standards of product quality but also significantly enhances accessibility and supply chain assurance.
The VitBase embryo processing solution is the first of the 11 culture media in the GEMS embryo culture medium series to obtain medical device approval, which not only signifies the gradual localization of international first-class culture medium technology but also brings products with medical device registration certificates to the industry, laying the foundation for the subsequent localization of the entire series of culture media in China
