開立醫療(300633.SZ):申報醫療器械註冊獲得批准 涉及電子上消化道內窺鏡(EG-P550N)
格隆匯2月10日丨開立醫療(300633.SZ)公佈,公司的一種醫療器械產品已獲廣東省藥品監督管理局批准,於近日取得中華人民共和國醫療器械註冊證,證書批准日期為:2022年1月30日,生效日期為:2022年1月30日,有效期至:2027年1月29日,註冊證編號:粵械注準20222060196。產品的基本信息如下:

該醫療器械產品目前已完成第二類醫療器械註冊證核發,並取得了《中華人民共和國醫療器械註冊證》。
與普通胃鏡(9.3mm)外徑相比,EG-P550N的外徑僅有(5.8mm)。更纖細柔軟的外徑,在檢查過程中能顯著降低患者痛苦,嘔吐情況有明顯改善。對食管狹窄者、急危重症、年老體弱和心肺功能欠佳的患者進行胃鏡檢查時,不僅首次狹窄段通過率提高,而且預擴張的次數減少,操作時間縮短,提高了心肺功能不全患者內鏡下治療的安全性。同時EG-P550N有着優秀的成像效果,診斷準確率更高。超細胃鏡可在食道病檢查、胃病檢查、幽門螺桿菌檢查等鏡下介入治療中廣泛使用。
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