戴維醫療(300314.SZ):新生兒黃疸治療燈完成醫療器械產品註冊變更
格隆匯2月8日丨戴維醫療(300314.SZ)公佈,公司於近日取得由浙江省藥品監督管理局頒發的1項《醫療器械註冊變更文件》,公司產品新生兒黃疸治療燈完成了醫療器械產品註冊變更。變更內容系:
1、型號規格:由“YG-Ⅰ、YG-Ⅱ、YG-Ⅲ”變更為“YG-Ⅰ、YG-Ⅱ、YG-Ⅲ、YG-Ⅳ”。
2、結構及組成:由“產品由燈箱組件、吸盤、電源適配器(僅適用於YG-Ⅲ)和支臂組件(僅適用於YG-Ⅲ,可選件)組成。”變更為“產品由燈箱組件、吸盤(僅適用於YG-Ⅰ、YG-Ⅱ、YG-Ⅲ)、電源適配器(僅適用於YG-Ⅲ)、控制儀(僅適用於YG-Ⅳ)和支臂組件【僅適用於YG-Ⅲ(可選件)、YG-Ⅳ】組成。”
3、註冊證產品技術要求發生相應變更。
公司表示,上述《醫療器械註冊證》的變更,有利於進一步提升公司在嬰兒保育設備領域的核心競爭力,對公司未來經營將產生積極影響。
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