迪瑞醫療(300396.SZ)取得16項《醫療器械註冊證》
格隆匯11月13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16項《醫療器械註冊證》。
化學發光免疫分析作為體外診斷行業最重要的細分項目之一，其臨牀應用涵蓋多個病種，包括腫瘤、甲功、激素、傳染病、心臟標誌物等。化學發光免疫分析技術目前在歐美等發達國家已經成為臨牀試驗室廣泛使用的常規檢測技術。對於國內市場來説，目前化學發光檢測產品大部分為國外大廠商生產的產品，我國化學發光檢測產業還處於發展期。不過隨着國內廠商技術的不斷進步，差距在不斷縮小，近些年國內湧現出了一批較具代表性的廠家。
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。
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。
公司此次取得註冊的CSM-8000模塊化生化免疫分析系統、MUS-3600全自動尿液分析系統、CS-2000全自動生化分析儀、CS-T240Plus全自動生化分析儀等產品，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。新增的12項化學發光免疫分析試劑產品，進一步增加了公司免疫檢驗產品項目，可為疾病診療提供精準依據。
上述《醫療器械註冊證》的取得，豐富了公司產品種類，將進一步增強公司產品的綜合競爭力，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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