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戴維醫療(300314.SZ):嬰兒正壓呼吸管路系統獲得醫療器械註冊證
格隆匯 01-03 15:58

格隆匯1月3日丨戴維醫療(300314.SZ)公佈,公司全資子公司寧波維爾凱迪醫療器械有限公司(簡稱“維爾凱迪”)於近日收到浙江省藥品監督管理局頒發的《醫療器械註冊證》。

產品名稱:嬰兒正壓呼吸管路系統;型號、規格:DC-12-BWH-01;註冊證編號:浙械注準20222081273;批准日期:2022年12月21日;有效期至:2027年12月20日;註冊分類:Ⅱ類;適用範圍:產品與呼吸濕化器、空氣源、氧氣源和空氧混合器配套使用,建立病人呼吸的通道,提供給有自主呼吸的嬰兒(體重小於15公斤的新生兒和嬰兒)持續正壓呼吸支持,設計用於醫療機構為需要輔助呼吸的非插管的嬰兒提供呼吸支持。

公司表示,維爾凱迪該次獲註冊的嬰兒正壓呼吸管路系統用於正壓呼吸治療即CPAP療法,提供給嬰兒或新生兒自主呼吸所需要的、持續的氣道壓力,系統管路可輸送温暖濕潤的氣體,為患者提供一套完整舒適的呼吸治療及護理的解決方案。

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