BASECARE-B (02170) Receives NMPA Class III Medical Device Approval for Gems Cleavage-Stage Embryo Culture Medium

Stock News
May 13

BASECARE-B (02170) announced that its independently developed Gems cleavage-stage embryo culture medium has recently been approved by the National Medical Products Administration (NMPA) and granted a Class III Medical Device Registration Certificate (Certificate No.: Guo Xie Zhu Jin 20263180177). Prior to this approval, the Gems culture medium had already obtained the European Conformity (CE) mark, U.S. Food and Drug Administration (FDA) certification, and Australian Therapeutic Goods Administration (TGA) certification. The Gems culture medium is built upon 30 years of technological expertise from Sydney IVF Centre and has undergone 13 years of overseas clinical validation. It has been iteratively upgraded by incorporating patient clinical characteristics and actual diagnostic needs, adding multiple antioxidant components, and precisely optimizing the nutritional formula. While retaining the high stability advantages of the original formulation, it further enhances the early embryo's stress resistance and developmental support, making it better suited for domestic assisted reproductive clinical requirements. This approval signifies that all four core products in the Gems series have now obtained certification, completing the full sequential culture medium series. This achievement establishes a comprehensive and compliant portfolio for the core embryo culture product category, forming a key closed-loop for the full-cycle culture system and providing clinicians with highly flexible options.

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