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永勝醫療(01612.HK)呼吸濕化治療儀獲藥監局發出醫療器械註冊證
格隆匯 02-19 17:03

格隆匯2月19日丨永勝醫療(01612.HK)發佈公告,2020年2月17日,集團獲得國家藥品監督管理局對其呼吸濕化治療儀(型號:VUN-001)(“O2 FLO呼吸濕化治療儀”)以及相關配件及一次性產品發出醫療器械註冊證。

根據披露,O2 FLO呼吸濕化治療儀是非侵入式高流量給氧治療器械,用於治療慢性或急性呼吸窘迫,例如肺炎、病毒性肺炎、慢性阻塞性肺病、心臟衰竭和哮喘的患者。高流量給氧治療是通過向患者輸出高流量的經加熱和濕化的空氣而提供呼吸支持的一種方式,臨牀證實對合適的患者採用高流量給氧治療可以改善氧合作用,能減少患者的呼吸作功,是一種相比侵入性機械通氣更經濟、更安全和更容易使用的替代治療。O2 FLO呼吸濕化治療儀已分別於2018年8月獲日本厚生 働省註冊認證及於2019年11月獲Conformité Européenne認證。集團看到該器械在日本的銷售向好,同時在認可CE認證的國家對該器械的關注與日俱增。

公告表示,集團已收到來自湖北省對O2 FLO呼吸濕化治療儀及其相關一次性產品的初步訂單。集團相信該器械具有良好的市場潛力,並將令集團的產品組合更為豐富。除中國、日本和歐洲聯盟以外,集團亦致力於美國和其他國家註冊及推出該器械。

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