陽普醫療(300030.SZ)收到醫療器械註冊變更文件 增加血栓彈力圖儀產品適用機型
格隆匯11月8日丨陽普醫療(300030.SZ)公佈,近日,公司收到了由廣東省藥品監督管理局頒發的《中華人民共和國醫療器械註冊變更文件(體外診斷試劑)》。
其中,產品名稱:活化凝血檢測試劑盒(凝固法);變更內容:1、註冊證附件“產品技術要求”發生變更。2、適用機型、註冊證附件“產品説明書”發生變更。
產品名稱:肝素酶包被試劑杯;變更內容:1、註冊證附件“產品技術要求”發生變更。2、適用機型、註冊證附件“產品説明書”發生變更。
產品名稱:血栓彈力圖質控品水平Ⅰ;變更內容:1、註冊證附件“產品技術要求”發生變更。2、適用機型、註冊證附件“產品説明書”發生變更。
公司表示,此次變更主要增加了公司血栓彈力圖儀產品的適用機型,進一步豐富了該產品系列的檢測平台,有助於促進血栓彈力圖儀產品的配套銷售,增強血栓彈力圖儀的市場競爭力和推廣效率,對公司未來經營將產生正面影響。
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