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愛朋醫療(300753.SZ):“固定保持止鼾器”獲醫療器械註冊證
格隆匯 11-25 08:36

格隆匯11月25日丨愛朋醫療(300753.SZ)公佈,公司的全資子公司愛朋醫療科技(湖南)有限公司近日取得湖南省藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》。產品名稱:固定保持止鼾器;註冊證編號:湘械注準20222142081;註冊證有效期:2022年11月11日至2027年11月10日;註冊分類:第二類;適用範圍:可使患者下頜前伸,用於睡眠打鼾或阻塞式呼吸暫停的輔助治療。

公司註冊的“固定保持止鼾器”是公司研發項目“鼾症口腔矯治器”的成果,主要是針對睡眠打鼾或打鼾伴有呼吸暫停的人羣研發的產品。用户可個性化塑形調節止鼾器,睡眠時將已調節好的產品戴入口中,通過上下齒咬合固定保持止鼾器,使得氣道呼吸阻塞處從齶嚥到舌咽都有明顯擴張,從而保持上氣道暢通,以此消除或降低呼吸暫停和鼾聲(俗稱“打呼嚕”)並提高睡眠質量。固定保持止鼾器作為一種輕診療方式,可作為單純鼾症和輕、中度OSA患者的一線治療方法,具有療效穩定、可逆舒適、便攜方便、不適感低、依從性好、無噪音、性價比高等優勢,可單獨使用亦可配合其他多種治療手段使用。

公司積極佈局上氣道健康管理的細分市場——健康睡眠領域,目前擁有知了睡眠AI鼾聲監測軟件、安波瀾便攜多導睡眠記錄系統、血氧飽和度傳感器等產品。隨着固定保持止鼾器註冊證的獲批,使公司擁有了除睡眠監測、記錄外直接緩解或治療輕、中度OSA及鼾症的產品,豐富了公司睡眠領域用產品種類,能夠更好地打開市場,有利於進一步提高公司的市場拓展能力,對公司未來的經營將產生積極影響。

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