理邦儀器(300206.SZ):X系列病人監護儀獲得醫療器械註冊證
格隆匯11月14日丨理邦儀器(300206.SZ)公佈,公司於近日取得了國家藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》(“《醫療器械註冊證》”)。
產品名稱為病人監護儀;臨牀用途為X8、X8A、X8B、eHM5型產品適用於在醫療單位中供有資質的人員操作,對成人、小兒、新生兒進行心電(ECG)(含ST段測量、QT/QTc測量、心律失常分析)和心率(HR)、呼吸(RESP)、體温(TEMP)、脈搏血氧飽和度(SpO2)、脈率(PR)、無創血壓(NIBP)、呼吸末二氧化碳(CO2)的監護;X10、X10A、X10B、eHM6型產品適用於在醫療單位中供有資質的人員操作,對成人、小兒、新生兒進行心電(ECG)(含ST段測量、QT/QTc測量、心律失常分析)和心率(HR)、呼吸(RESP)、體温(TEMP)、脈搏血氧飽和度(SpO2)、脈率(PR)、無創血壓(NIBP)、呼吸末二氧化碳(CO2)、有創血壓(IBP)的監護;X12、X12A、X12B、eHM7型產品適用於在醫療單位中供有資質的人員操作,對成人、小兒、新生兒進行心電(ECG)(含ST段測量、QT/QTc測量、心律失常分析)和心率(HR)、呼吸(RESP)、體温(TEMP)、脈搏血氧飽和度(SpO2)、脈率(PR)、無創血壓(NIBP)、呼吸末二氧化碳(CO2)、有創血壓(IBP)、心排量(C.O.)(僅限成人患者)的監護;監護信息可以顯示、回顧、存儲、打印並提供報警,並可通過有線或無線的方式將監護信息傳輸至中央監護系統上。
上述《醫療器械註冊證》的取得,豐富了公司病人監護儀的種類,進一步增強了公司在監護產品的綜合競爭力,對公司未來的發展具有積極影響。
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