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戴維醫療(300314.SZ):嬰兒轉運培養箱完成了醫療器械產品註冊變更
格隆匯 02-14 16:50

格隆匯2月14日丨戴維醫療(300314.SZ)公佈,公司於近日取得由國家藥品監督管理局頒發的1項《醫療器械變更註冊(備案)文》,公司產品嬰兒轉運培養箱完成了醫療器械產品註冊變更

變更內容:

1、產品名稱:由“運輸用培養箱”變更為“嬰兒轉運培養箱”

2型號規格TI-2000TI-900變更為TI-2000TI-900TI-2100TI-2100ATI-2100BTI-3000TI-3000ATI-3000B

3適用範圍由“用於短距離內對早產兒的轉運。”變更為於為低體重嬰兒、病危病弱兒、早產兒提供一個空氣潔淨、温度適宜的培養治療環境,幫助醫療機構安全地轉運嬰兒,TI-2100ATI-2100BTI-3000ATI-3000B還可用於患兒動脈血氧飽和度(SpO2)和脈搏率(PR)的連續無創測量。

4註冊證產品技術要求發生相應變更。

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。上述產品的實際銷售情況取決於未來市場推廣效果,公司目前尚無法預測其對公司未來業績的影響。

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