樂心醫療(300562.SZ):申請的臂式電子血壓計醫療器械註冊證許可事項變更已獲受理
格隆匯 4 月 30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》,獲知公司申請的臂式電子血壓計醫療器械註冊證許可事項變更已獲得廣東藥監局的受理(受理號:0010600420210201),具體情況如下:

上述臂式電子血壓計為2.4GHz頻段的小功耗數據通信系統的無線設備,採用示波測量法,可測量的上臂周長約22cm-32cm。產品包括氣泵模塊、MCU芯片模塊、WIFI模塊和電源適配器,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,通過WIFI無線網絡自動上傳相關測量數據至智能健康雲平台進行數據的分析與整理,並形成實時的健康圖表及報吿,反饋至用户的APP或者微信公眾號綁定的相關賬號,便於用户隨時隨地瞭解個人及其家庭成員的健康數據,掌控健康趨勢。
此次臂式電子血壓計醫療器械註冊證許可事項變更申請獲得受理後,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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