迪瑞醫療(300396.SZ)取得31項醫療器械註冊證
格隆匯6月11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31項《醫療器械註冊證》。
其中，編號：吉械注準20152400069、吉械注準20152400070、吉械注準20152400071、吉械注準20152400072、吉械注準20152400073、吉械注準20152400074、吉械注準20152400075、吉械注準20152400076、吉械注準20152400077、吉械注準20152400078的《醫療器械註冊證》為延續註冊產品。
此次取得的註冊產品涉及IVD行業中化學發光免疫分析，生化診斷分析和尿液分析等。化學發光免疫分析應用涵蓋多個病種，包括腫瘤、甲功、激素、傳染病、心肌標誌物等。生化診斷是最早實現自動化的檢測手段，目前醫療衞生機構是消費生化試劑產品的主力軍。尿液分析技術國內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，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。
其中，新取得的維生素複合校準品、維生素複合質控品屬於質譜技術的相關試劑，維生素複合校準品、維生素複合質控品涉及維生素五個項目的測試。質譜技術具有不依賴抗體既能區別眾多分子間微小的分子量差異的優勢在臨牀中有着不可替代的應用潛力。公司取得的維生素複合校準品能夠保證量值的溯源性，維生素複合質控品能夠控制測試系統的質量，保證結果的準確性。
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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