樂心醫療(300562.SZ):收到電子血壓計醫療器械註冊變更文件
格隆匯6月2日丨樂心醫療(300562.SZ)公佈,公司於近日收到由廣東省藥品監督管理局(“廣東藥監局”)頒發的《醫療器械註冊變更文件》,產品名稱為電子血壓計,註冊證編號為粵械注準20192071008;註冊證有效期為2019-09-24至2024-09-23。
此次公司醫療器械註冊證的變更,主要是電子血壓計產品增加了TMB-1491-DS、TMB-1491-S型號規格,結構及組成變更為“由主機、袖帶和電源適配器(型號TMB-1491-S不適用)組成”,並對產品技術要求做了部分變更。新增血壓計產品主要由公司自主知識產權研發的主機、袖帶組成,更新了產品外觀、刪除通訊功能和改變供電方式。產品包括氣泵模塊、MCU芯片模塊和電源(型號TMB-1491-S不適用),連接袖帶氣管插頭與主機完成血壓原始數據收集經由模擬示波算法計算得出血壓值。
樂心醫療一直致力於針對運動健康、慢病管理等領域為行業客户提供健康IoT和智能健康整體解決方案,專業從事醫療健康產品、智能可穿戴產品的研發、生產與銷售以及樂心智能健康雲平台的研發與運營。上述電子血壓計產品《醫療器械註冊證》變更後,將豐富樂心醫療產品種類,有利於進一步增強公司產品的綜合競爭力和市場拓展能力,對公司未來的經營將產生積極影響。公司未來會積極推動相關產品在國內外市場的銷售,為廣大股東創造更大的價值。上述產品實際銷售情況取決於未來市場推廣效果,公司目前尚無法預測其對公司未來業績的影響,敬請投資者注意投資風險。
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