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迪瑞醫療(300396.SZ)取得4項醫療器械註冊證
格隆匯 04-14 19:55

格隆匯4月14日丨迪瑞醫療(300396.SZ)公佈,公司於近日取得由吉林省藥品監督管理局頒發的4項《醫療器械註冊證》,產品名稱為全自動尿液分析系統;總膽紅素測定試劑盒(釩酸鹽氧化法);胰澱粉酶測定試劑盒(酶比色法);直接膽紅素測定試劑盒(釩酸鹽氧化法)。

尿液分析技術目前在國內外已經成為臨牀檢驗項目的常規檢測技術,隨着國內廠商技術不斷進步,與國外尿液分析產品的差距不斷縮小,在二級及基層醫院市場逐漸完成了進口產品替代,並不斷搶佔進口尿液分析產品的市場份額。公司在尿液分析領域多年來積累了較強的產品、品牌優勢和技術儲備,公司推出的系列流水線產品代表國際一流技術水平。

公司此次取得註冊的MUS-9600全自動尿液分析系統,積蓄在尿液分析領域的深厚底藴,結合尿有形成分、幹化學、理學一體化設計理念,可提供豐富的尿液檢測報告參數,採用新型封閉尿液標本採集器,保障生物安全。可滿足實驗室對自動化、信息化、智能化解決方案的需求,同時有效的縮短了檢驗工作時間,提升了工作效率。

延續註冊的3項試劑屬於生化分析產品,生化診斷是最早實現自動化的檢測手段,也是目前最常用的體外診斷方法之一。我國的體外診斷產業經過三十多年來的發展,已經形成了一定的規模並且與臨牀的需求基本相適應。目前,醫療衞生機構是消費生化試劑產品的主力軍。

公司堅持儀器與試劑研發並行開拓,積極豐富和優化產品結構,上述《醫療器械註冊證》的取得,豐富和延續了公司產品種類,將進一步增強公司綜合競爭力,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。上述產品實際銷售情況取決於未來市場推廣效果,公司目前尚無法預測其對公司未來業績的影響,敬請投資者注意投資風險。公司未來會積極推動相關產品在國內市場的銷售,為廣大股東創造更大的價值。

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