重藥控股(000950.SZ):半自動體外除顫儀獲得三類醫療器械註冊證
格隆匯1月21日丨重藥控股(000950.SZ)公佈,公司下屬子公司重慶醫藥集團席勒醫療設備有限公司(“席勒醫療”)於2021年1月20日收到國家藥品監督管理局頒佈的《中華人民共和國醫療器械註冊證》,產品名稱為半自動體外除顫儀。
適用範圍為用於沒有反應、沒有呼吸、沒有脈搏的室顫患者以及心率大於180次/每分鐘的室速患者的體外除顫,適用於體重≥25公斤的成人和小兒(使用成人電極片)以及體重<25公斤(年齡小於8歲)的小兒(使用小兒電極片)。該產品在公眾場所、醫療場所中使用,應由接受過心肺復甦和自動體外除顫器使用培訓合格的人員使用,由接受過基本生命支持和高級生命支持課程培訓合格的醫務人員使用,或者在急救中心調度人員指導下使用。
上述醫療器械的上市銷售,填補了公司在高端醫療器械生產領域的空白,有利於增強公司綜合競爭力。
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