苏州贝康医疗股份有限公司（2170.HK）宣布，其“Gems Cleavage胚胎培养液”产品已获得中国国家药品监督管理局（NMPA）颁发的三类医疗器械注册证。
三类医疗器械是监管等级最高的医疗器械类别，通常用于支持或维持生命，或具有潜在风险，需严格管理。此次获批标志着该产品在辅助生殖领域的应用获得了官方认可，符合中国相关法规的最高标准。
胚胎培养液是辅助生殖技术（ART）中的关键耗材，用于在体外受精（IVF）过程中培育胚胎。该产品的获批有望为贝康医疗在快速增长的中国辅助生殖市场提供新的增长动力。
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