鱼跃医疗(002223.SZ):持续葡萄糖监测系统取得医疗器械注册证

智通财经
04 Feb

智通财经APP讯,鱼跃医疗(002223.SZ)发布公告,公司控股子公司江苏鱼跃凯立特生物科技有限公司近日收到了国家药品监督管理局颁发的关于持续葡萄糖监测系统(“CGM”)的《医疗器械注册证》。

该产品可用于糖尿病成年患者(≥18岁)的组织间液葡萄糖水平的连续或定期监测,可提供并存储实时葡萄糖值,供用户跟踪葡萄糖浓度变化的趋势。如果葡萄糖水平低于或高于预设值,该产品可发出提示。Anytime 4H、Anytime 4H Plus、Anytime 4h、 Anytime 4h Plus 型号产品在医疗机构中使用,Anytime 4SE、 Anytime 4Pro、Anytime 4型号产品在家庭中使用,一次性葡萄糖传感器仅供单个用户使用,不需要用户进行校准,使用时间最长15天。该产品测量结果不作为决定和调整糖尿病患者治疗方案的依据。

本次获证的15天免校准/可校准双模式CGM产品,将可满足用户在医疗机构和家庭等多场景的使用需求,是公司在糖尿病护理解决方案领域不断推动产品迭代升级的成果体现,进一步丰富了公司相应板块的产品品类。公司将充分发挥相关产品在准确度、舒适性、便捷性以及数字化管理方面的优势,不断加深业务拓展,持续为用户提供更高质量的产品与服务。

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