BASECARE-B(02170): Gems cleavage embryo culture medium has been granted Class III medical device certificate by the National Medical Products Administration.
Becon Medical (02170) announced that its independently developed Gems cleavage embryo culture medium has recently obtained the registration certificate for Class III medical devices in the country (registration number: Guoxie Zhu 20263180177). Prior to this approval, Gems cleavage embryo culture medium had already obtained certifications including the European Union CE certification, the U.S. Food and Drug Administration (FDA) certification, and the Australian Therapeutic Goods Administration (TGA) certification.
BASECARE-B(02170) announced that the company's self-developed Gems blastocyst culture medium has recently been successfully approved for the registration of Class III medical devices in China (registration number: State Administration for Market Regulation 20263180177). Prior to this approval, Gems blastocyst culture medium has obtained the European CE certification, the United States Food and Drug Administration (FDA) certification, and the Australian Therapeutic Goods Administration (TGA) certification.
Based on the 30 years of technical accumulation of the Sydney IVF Center and 13 years of overseas clinical validation, Gems blastocyst culture medium has been iteratively upgraded to meet clinical characteristics and actual diagnosis and treatment needs of patients, adding multiple antioxidant components and optimizing nutrition ratios precisely. While retaining the high stability advantage of the original formula, it further enhances the early embryo's anti-stress ability and developmental support effects, making it more suitable for domestic assisted reproduction clinical needs.
This approval marks the full certification of the four core main culture products in the Gems series, completing the full range of sequential culture media and the complete compliance layout of core embryo culture categories. It establishes a key closed-loop system for the full cycle of culture, providing a highly flexible choice space for clinical use.
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