樂心醫療(300562.SZ):腕式電子血壓計延續註冊申請獲得受理
格隆匯 1 月 28日丨樂心醫療(300562.SZ)公佈,公司於近日收到廣東省藥品監督管理局(“廣東藥監局”)發的《受理憑證》,獲知公司的腕式電子血壓計的延續註冊申請已獲廣東藥監局受理(受理號:0010600220210086),具體情況如下:

腕式電子血壓計適用於以示波測量成人的收縮壓、舒張壓和脈率,監測血壓變化情況,為用户提供科學的血壓診斷參考。該產品採用藍膜LCD顯示,測量方式為示波測量法,主要元器件包括氣泵、排氣閥、MCU、傳感器;可測量的手腕周長約13.5cm-19.5cm,能保存60組測量數據,並能對已存儲的每個記錄進行翻查,也能對用户的測量記錄進行全部刪除,是一款適用於家庭使用的精密血壓測量儀器。
此次腕式電子血壓計延續註冊申請獲得受理後,仍需取得廣東藥監局的延續註冊核准,延續註冊核准手續是否獲得通過仍存在不確定性。因此,公司尚無法預測其對公司未來業績的影響,公司將根據本次註冊的進展情況及時履行信息披露義務。
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