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健帆生物(300529.SZ):中空纖維血液透析器產品取得歐盟CE認證

格隆匯3月30日丨健帆生物(300529.SZ)公佈,公司之全資子公司珠海健航生產的中空纖維血液透析器(高通)、中空纖維血液透析器(低通)經TUV南德批准,取得歐盟CE證書。該產品獲得歐盟CE認證後,可以在歐盟國家及其他認可歐盟CE認證國家進行銷售。

公司的新產品中空纖維血液透析器(高通系列/低通系列)為血液淨化領域的膜分離技術產品,進一步豐富了公司血液淨化產業鏈的產品種類。血液透析器能與公司現有的血液灌流器等產品產生協同作用,有利於公司為海外血液透析患者提供更全面、高質量的產品及服務。

該新產品獲得歐盟CE認證後,將具備歐盟國家及其他認可歐盟CE認證國家的銷售准入資格。本次新產品是在歐盟MDR新法規下完成的認證,其中高通系列的中空纖維血液透析器共13個品規,低通系列的中空纖維血液透析器共11個品規,覆蓋了該產品的市場通用規格,能更好地滿足國際上血透患者多樣化的治療需求,進一步提升了公司的國際化競爭力,並對公司的國際業務拓展帶來積極作用,將對公司整體的經營產生積極影響。

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