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大博醫療(002901.SZ)子公司獲醫療器械註冊證及醫療器械生產許可證
格隆匯 12-12 17:11

格隆匯12月12日丨大博醫療(002901.SZ)公佈,公司的全資子公司百齒泰(廈門)醫療科技有限公司於近日取得國家藥品監督管理局頒發的《醫療器械註冊證》以及福建省藥品監督管理局核發的《醫療器械生產許可證》。

一、《醫療器械註冊證》基本信息

產品名稱:種植體系統

註冊證有效期:2019年09月29日至2024年09月28日

註冊分類:第三類醫療器械

預期用途:牙種植體系統適用於牙缺失患者的種植修復,是用外科方法將種植體植入到人體缺失牙部位的頜骨組織上或組織內,為義齒提供支持和固位的醫用裝置。

二、《醫療器械生產許可證》基本信息

企業名稱:百齒泰(廈門)醫療科技有限公司

生產範圍:三類17-08口腔植入及組織重建材料

許可證編號:閩食藥監械生產許20190431號

有效期限:2019年12月03日至2024年12月02日

上述產品註冊證及生產許可證的取得,將進一步豐富公司的產品線,有利於增強公司的綜合競爭力。

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