贝康医疗-B(02170):GEMS取卵液获国家药监局颁发三类医疗器械注册证

智通财经
May 29

智通财经APP讯,贝康医疗-B(02170)发布公告,本公司Gems系列的取卵液于近日获得国家药品监督管理局(国家药监局)颁发的三类医疗器械注册证(注册证号:国械注进20263180183)。

取卵液是IVF诊疗第一道核心试剂,为后续受精、卵裂、囊胚发育提供前置保障。本品添加硫酸庆大霉素,有效规避样本污染风险;搭载HEPES缓冲体系,可在非培养环境下稳定维持酸硷度,适配各类取卵操作场景。产品性能稳定,货架有效期长达52周,大幅提升临床使用便利性与实用性。

本次获批标志着Gems系列试剂逐步完成全品类闭环布局。目前取卵液、胚胎处理液、受精液、卵裂胚培养液、囊胚培养液、胚胎培养液六款产品已全部拿证,覆盖取卵、配子处理、受精、胚胎培养全诊疗链路。

Gems系列辅助生殖用液拥有三十年IVF试剂品牌研发历史,由国际知名胚胎培养领域权威、“培养液之父”David Mortimer于悉尼IVF中心领衔研发,依托全球前沿的胚胎发育研究理论,打造出更适配人类胚胎发育规律的科学配方。产品历经十三年全球多中心临床应用验证,长期临床表现稳定、安全、有效。同时全系产品斩获欧洲合格认证(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)多重国际权威认证证,严苛遵循国际顶级生产与质控标准,过硬的产品实力获得全球生殖领域专家的广泛认可与深度信赖。

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