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大博醫療(002901.SZ)及子公司各獲1項第三類醫療器械註冊證
格隆匯 11-29 16:21

格隆匯11月29日丨大博醫療(002901.SZ)公佈,公司及其全資子公司博益寧(廈門)醫療器械有限公司於近日分別取得國家藥品監督管理局頒發的第三類《醫療器械註冊證》。

其中,產品名稱:頸椎前路釘板固定系統;註冊人名稱:大博醫療科技股份有限公司;註冊分類:第三類醫療器械;註冊證有效期:至2026年10月13日。該產品由頸椎前路固定板和螺釘組成,非滅菌包裝和滅菌包裝,滅菌有效期為5年;適用於頸椎前路內固定。

產品名稱:頸椎後路內固定系統;註冊人名稱:博益寧(廈門)醫療器械有限公司;註冊分類:第三類醫療器械;註冊證有效期:至2026年10月13日。頸椎後路內固定系統由矯形釘、螺母、連接棒、側方連接器、椎板鈎、枕頸融合塊、枕頸固定釘、橫連鈎、橫連桿、橫連器組成。非滅菌和滅菌包裝,滅菌包裝為輻照滅菌,滅菌有效期為5年;適用於枕骨-C7節段後路的內固定。

公司表示,上述產品註冊證的取得,有利於公司及全資子公司進一步拓展脊柱產品線業務,增強公司的綜合競爭力,預計將對公司未來的經營產生積極的影響。

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