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戴維醫療(300314.SZ):亞低温治療儀申報醫療器械註冊獲受理
格隆匯 09-28 16:44

格隆匯9月28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《受理通知書》。受理號:械受202110176;產品名稱:亞低温治療儀;註冊分類:II類;臨牀用途:適用於醫療機構對患者(小於等於10KG)全身或局部進行物理降温或升温,達到調控體温的目的。

亞低温治療儀是採用物理降温的方式將患者體温降低到預期水平來幫助醫生治療疾病的設備,自從臨牀研究發現亞低温是臨牀上可行的改善HIE新生兒預後的手段,近年來亞低温治療儀的發展速度越來越快,國內醫療機構已經開始使用亞低温治療新生兒缺氧缺血性腦病。

公司在註冊的亞低温治療儀採用半導體控温技術,是公司自主研發的一款擁有多項自主知識產權的新型嬰兒物理控温設備。產品各項性能符合嬰兒物理控温設備的要求,幷包含了三種控制模式(自動操作模式、恆温直腸模式、恆温毯模式),使其在臨牀應用上可滿足多種需求,具有較強的市場競爭優勢。

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