智通财经APP讯，贝康医疗-B(02170)发布公告，公司自主研发的Gems卵裂胚培养液于近日成功获批国家三类医疗器械注册证(注册证编号：国械注进20263180177)。在此次获批之前，Gems卵裂胚培养液已分别取得欧洲合格认证(CE)、 美 国食品药品监督管理局(Food and Drug Administration)(FDA)认证及澳大利亚药品管理局(Therapeutic Goods Administration)(TGA)认证。
Gems卵裂胚培养液，依托悉尼IVF中心30年技术积淀，历经13年海外临床验证，结合患者临床特征与实际诊疗需求完成迭代升级，新增多重抗氧化成分、精准优化营养配比，在保留原配方高稳定性优势的同时，进一步提升早期胚胎抗应激能力与发育支撑效果，更适配国内辅助生殖临床需求。
本次获批标志着Gems系列四大核心主培产品全线获证，补齐了序贯培养液完整系列，完成了胚胎培养核心品类的完整合规布局，构建起全周期培养体系关键闭环，可为临床提供高度灵活的选择空间。
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