開立醫療(300633.SZ):HD-550電子內窺鏡系統獲美FDA批准
格隆匯4月6日丨開立醫療(300633.SZ)公佈,公司的HD-550電子內窺鏡系統已獲美國FDA批准,於近日取得FDA 510(k) SE Letter,證書批准日期為2022年4月1日,無有效期限制,FDA510(k)註冊號為K211882。
HD-550系列是公司在2018年推出的全高清電子內鏡系統,產品技術處於國際先進、國內領先水平。繼HD-500系列產品獲FDA批准之後,HD-550系列產品亦獲得相關批准。
美國內窺鏡市場是全球最重要的消化內鏡市場之一,HD-550系列獲得FDA批准,將有利於開立醫療內窺鏡產品在北美市場乃至國際市場發揮影響力,進而獲得更多全球市場份額。
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