健帆生物(300529.SZ):Future F20血液淨化設備取得醫療器械註冊證
格隆匯8月3日丨健帆生物(300529.SZ)宣佈,公司於近日收到國家藥品監督管理頒發的《醫療器械註冊證》。產品名稱為血液淨化設備;規格及型號為Future F20;註冊證編號為國械注準20203100665;註冊證有效期為2020年7月28日至2025年7月27日;分類為III類。
該產品在體外血液淨化治療過程中提供動力及安全監測,與兼容的一次性使用耗材聯合使用,實現成人患者的血液灌流、血漿吸附和雙重血漿分子吸附治療。
新產品註冊證的取得,符合公司深耕血液淨化領域的戰略佈局。該Future F20血液淨化設備支持血液灌流(HP)、血漿吸附(PA)和雙重血漿分子吸附(DPMAS)等血液吸附治療模式,能與公司的HA系列灌流器和BS系列吸附器配合使用,為醫護和患者提供更優質的血液吸附治療服務。
該Future F20血液淨化設備進一步豐富了公司醫療設備產品線,與公司DX-10血液淨化機、JF-800A血液灌流機形成了差異化市場定位,構建了更加完整的血液淨化設備佈局,滿足了臨牀上對設備功能的不同需求,提高公司的整體競爭力,未來將對公司的經營發展帶來積極影響。
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