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三友醫療(688085.SH):超聲軟組織切割止血設備取得醫療器械註冊證
格隆匯 11-24 15:36

格隆匯11月24日丨三友醫療(688085.SH)公佈,公司的控股子公司水木天蓬近日收到國家藥品監督管理局頒發的“超聲軟組織切割止血設備”(簡稱“超聲止血刀”)《中華人民共和國醫療器械註冊證》,適用範圍:在醫療機構中使用,用於手術中對軟組織進行切割止血,可用於閉合直徑不超過3mm的血管。

超聲止血刀適用於所有手術中需要切割、凝血的部位,可廣泛應用於普通外科、泌尿外科、婦科及消化科等科室。在手術中,超聲止血刀可以高效地進行軟組織的切割並有效促進血管閉合,根據其特殊功率的反饋機制,可最大限度的減少對周圍軟組織的損傷,極大提高手術的便利性,憑藉其優良特性,超聲止血刀在臨牀應用中已逐漸表現出取代電刀的趨勢。

2019年水木天蓬作為獨家企業參與了國家食品藥品監督管理總局組織制定的中華人民共和國醫藥行業標準《超聲軟組織切割止血手術設備》(YY/T1750-2020),該標準已於2020年正式頒佈,2022年將正式實施。水木天蓬自主創新研發的超聲止血刀在中國的獲批上市,將打破進口廠家對國內該領域的壟斷地位,實現進口替代,對促進我國超聲止血刀市場的發展具有重要意義。

同時,亦將進一步豐富公司的產品種類,擴充公司在超聲能量領域的佈局,進一步提升公司的核心競爭能力。超聲止血刀此前已經取得了歐盟註冊證,此次在中國的獲批上市將進一步促進相關產品在國內市場的銷售,對公司未來的發展具有積極的影響。

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