BASECARE-B (02170) Receives NMPA Medical Device Registration Certificates for Fertilization and Blastocyst Culture Media

Stock News
Apr 07

BASECARE-B (02170) announced that two core culture media products from its Gems series—Fertilization Culture Medium and Blastocyst Culture Medium—were granted Class III Medical Device Registration Certificates by the National Medical Products Administration on April 2, 2026. The registration certificate numbers are State Instrument Note Jin 20263180127 and State Instrument Note Jin 20263180125. These newly certified media, together with the Geri Embryo Culture Medium approved in February of this year and the Embryo Handling Solution approved in 2025, complete the Gems full-series culture media matrix covering the entire process from fertilization to cleavage-stage embryo culture and blastocyst culture. The Fertilization Culture Medium is specifically designed to provide an optimal environment for oocytes and sperm to facilitate fertilization. The Blastocyst Culture Medium is suitable for culturing embryos from day-3 cleavage stage to day-5 or day-6 blastocyst stage, and is enriched with multiple amino acids and vitamin B12 to offer enhanced nutritional support for later-stage embryonic development. Geri is the world's only wet-type, full-time differential culture system, with over 1,000 units installed globally. It enables 24-hour uninterrupted monitoring without disturbing embryo development. When the Geri incubator is used with Gems culture media, its "triple antioxidant protection network" effectively addresses oxidative stress challenges in embryos from older patients, significantly simplifying laboratory operations and ensuring a stable culture environment. International clinical validation has shown that this combination can markedly increase the rates of high-quality blastocysts and clinical pregnancy. This approval signifies that the company has become one of the very few enterprises in the assisted reproductive fluid sector to simultaneously obtain four major international authoritative certifications: FDA, CE, TGA, and NMPA. The Chinese assisted reproduction market now welcomes its first local full-series culture media brand supported by international large-scale clinical trial data. Not only does it offer top-tier performance comparable to leading international brands, but it is also reshaping the standards of China's assisted reproduction industry through localized supply and robust clinical evidence.

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