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樂心醫療(300562.SZ):臂式電子血壓計的申報註冊已獲廣東藥監局受理
格隆匯 12-08 20:26

格隆匯12月8日丨樂心醫療(300562.SZ)公佈,公司近日收到廣東省藥品監督管理局(“廣東藥監局”)下發的《受理憑證》,獲知公司臂式電子血壓計的申報註冊已獲廣東藥監局受理(受理號:0010600120211138)。

上述臂式電子血壓計通過示波測量法、上升式測量技術測量人體的舒張壓、收縮壓、脈率,適用於上臂周長約22-42cm的成年人,測量數值供診斷參考。該血壓計主要元器件包括氣泵、電磁閥以及壓力傳感器,結構組成包括顯示器、面殼、氣泵、電源適配器等,通過壓力傳感器檢測袖帶測量到的血壓、脈搏耦合型號給MCU分析處理並顯示結果。用户通過下載、安裝APP,連接設備,可查看實時數據及歷史數據,瞭解個人及家人的健康情況。該款產品對公司加快建立和完善慢病管理領域健康IoT及遠程健康管理整體解決方案起到積極作用。

上述臂式電子血壓計的申報註冊獲得受理後,仍需取得廣東藥監局的進一步核准,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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