陽普醫療(300030.SZ):註冊變更增加了血栓彈力圖儀二代機型號規格T-400S
格隆匯5月26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》,涉及產品名稱為血栓彈力圖儀。
變更內容:1、為滿足市場需求,增加型號規格“T-400S”。2、註冊證產品技術要求發生變更。
備註:本文件與“粵械注準20172400740”註冊證共同使用。新《醫療器械分類目錄》管理類別:II類,分類編碼:22臨牀檢驗器械-01血液學分析設備。
此次註冊變更增加了血栓彈力圖儀二代機型號規格T-400S。二代機在原有核心平台技術的基礎上進行智能化優化,儀器性能更穩定、重複性更好,簡化操作並防止生物危害。血栓彈力圖儀二代機豐富了公司凝血產品的品規,形成了凝血產品系列化、差異化的競爭優勢,進一步夯實公司向IVD行業轉型的能力,對公司未來的經營將產生積極影響。
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