BASECARE-B (02170) Secures Class III Medical Device Registration Certificate from NMPA for GEMS Oocyte Retrieval Solution

Stock News
05/29

BASECARE-B (02170) announced that its GEMS series oocyte retrieval solution has recently been granted a Class III medical device registration certificate (Registration Certificate No.: Guo Xie Zhu Jin 20263180183) by the National Medical Products Administration (NMPA). The oocyte retrieval solution is a core reagent for the first step in IVF treatment, providing essential preconditions for subsequent fertilization, cleavage, and blastocyst development. This product contains gentamicin sulfate, effectively mitigating the risk of sample contamination. Equipped with a HEPES buffering system, it can maintain stable pH levels in non-culture environments, making it suitable for various oocyte retrieval procedures. With stable performance and a shelf life of up to 52 weeks, the product significantly enhances clinical convenience and utility. This approval marks the progressive completion of a full-category, closed-loop layout for the GEMS series. Currently, six products—oocyte retrieval solution, embryo handling solution, fertilization solution, cleavage-stage embryo culture medium, blastocyst culture medium, and embryo culture medium—have all obtained certification, covering the entire treatment pathway from oocyte retrieval, gamete handling, and fertilization to embryo culture. The GEMS series of assisted reproductive fluids boasts a thirty-year history of IVF reagent brand development. Led by David Mortimer, an internationally recognized authority in the field of embryo culture and known as the "Father of Culture Media," at the Sydney IVF Centre, the series is based on cutting-edge global research on embryonic development, creating scientific formulations better suited to the patterns of human embryo development. The products have undergone thirteen years of global multicenter clinical application validation, demonstrating stable, safe, and effective long-term clinical performance. Simultaneously, the entire series has obtained multiple international authoritative certifications, including the European Conformity (CE) mark, U.S. Food and Drug Administration (FDA) certification, and Australian Therapeutic Goods Administration (TGA) approval. Adhering to stringent international top-tier production and quality control standards, the robust product strength has garnered widespread recognition and deep trust from experts in the global reproductive field.

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