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樂心醫療(300562.SZ)申報醫療器械註冊證獲受理 涉胎兒監護貼
格隆匯 01-22 21:32

格隆匯1月22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”)下發的《受理憑證》(受理號:0010600120200062),產品名稱為胎兒監護貼。

胎兒監護貼採用微壓力檢測原理來偵測胎心率,繪製胎心率曲線。胎兒的胎心跳動能量會通過羊水、子宮壁、母體腹部肌肉的衰減後最終到達母體的皮膚表面,表現為母體腹部皮膚表面的微微振動,這個振動能量會推動周圍的空氣產生縱波,胎兒監護貼通過微壓力傳感器檢測到這個縱波能量後,將其轉化為電壓輸出。經過放大和濾波後,轉換為數字信號。隨後進行數字信號處理,計算出胎兒心率,得到穩定的胎心曲線,並呈現在手機APP上。該產品小巧、精緻、便攜,給用户以親切感,不發射任何波能量,對胎兒無能量傷害,不需要耦合劑塗抹使用方便。

胎兒監護貼產品目前所處的審批階段為註冊申請受理,後續所需的審批流程為技術審評、行政審批、制證。上述產品註冊申請受理對公司近期業績不會產生影響,審評在各階段所需的時間和結果均具有一定的不確定性,因此,公司尚無法預測其對公司未來業績的影響,公司將根據此次註冊的進展情況及時履行信息披露義務。

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