迪瑞醫療(300396.SZ)獲得2項醫療器械註冊證
格隆匯8月23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2項《醫療器械註冊證》。
1.產品名稱全自動尿液分析系統;臨牀用途:用於對人體尿液中理化指標以及尿液中有形成分進行定性、定量分析。
2.產品名稱全自動糖化血紅蛋白分析儀;臨牀用途:用於人體全血樣本或溶血樣本中糖化血紅蛋白的定量分析。
目前尿液分析技術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,新註冊的FUS-1000Plus型號全自動尿液分析系統,具有體積小巧、操作便捷等特性,一次進樣即可完成尿液幹化學及有形成分檢測,並具備多種測試模式可供選擇,可較好的滿足檢驗科及實驗室檢測需求。
糖尿病是全世界最主要的慢性非傳染性疾病之一,我國是糖尿病患病率增長最快的國家之一。糖化血紅蛋白是糖尿病患者判斷疾病控制程度的一項良好指標,可反映2-3個月的階段性血糖水平。糖化血紅蛋白作為糖尿病篩選、診斷、血糖控制、療效考核的有效檢測指標,在臨牀中得到了廣泛的使用。近年來,國內廠商在糖化血紅蛋白檢測系統領域不斷突破。公司此次新註冊的AH-100全自動糖化血紅蛋白分析儀,在臨牀樣本檢測中具有針對性強、自動化程度高、體積小、操作便捷等特性,可提供糖化血紅蛋白的動態檢測,為疾病篩查、預防及治療方案調整等方面提供重要依據。
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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