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樂心醫療(300562.SZ):上臂式電子血壓計的申報註冊獲得受理
格隆匯 03-07 20:23

格隆匯3月7日丨樂心醫療(300562.SZ)公佈,公司於近日到廣東省藥品監督管理局(廣東藥監局)下發《受理憑證》(受理號:0010600120220095)及《醫療器械生產許可證》(許可證編號:粵食藥監械生產 20071486 號)。

申請獲得受理相關情況:

上述上臂式電子血壓計由主機、袖帶、適配器組成,採用示波法測量人體(成人)的血壓和脈率,測量的數據通過液晶顯示屏顯示,其數值供臨牀參考,其中部分型號產品還可通過低功耗藍牙通信上傳至指定的APP軟件。以上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。

上述上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。

公司近日取得廣東藥監局下發的醫療器械生產許可證,具體內容如下:

生產地址:中山市火炬開發區東利路105號B區(1棟4、5層,2棟1、2、3層,3棟1層)

生產範圍:II類07醫用診察和監護器械-03生理參數分析測量設備,II類18婦產科、輔助生殖和避孕器械-02婦產科測量、監護設備

有效期限:至2024年08月11日

許可證編號:粵食藥監械生產許20071486號

公司致力於成為世界級的健康IoT及數字健康服務提供商,始終高度重視醫療器械標準符合性,推動全系列產品向醫療級方向發展。此次生產許可證的變更系由於公司增加經皮黃疸儀的生產許可,該生產許可的增加有利於增強公司的綜合競爭力和市場拓展能力,完善公司醫療器械資質體系,對公司未來的經營將產生積極影響。公司目前尚無法預測其對公司未來業績的影響。

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