昊海生物科技(06826.HK)控股子公司模注成型、疏水性人工晶狀體產品獲歐盟CE認證
格隆匯 2 月 1日丨昊海生物科技(06826.HK)發佈公吿,公司控股子公司河南賽美視生物科技有限公司及其美國全資子公司Simedice Biotechnologies Inc.於近日分別獲得了關於可摺疊、疏水性丙烯酸酯、單焦、非球面人工晶狀體產品的歐盟CE認證證書。該產品生產工藝採用創新性模注成型技術,系公司首個於全球範圍內獲得上市許可的疏水性人工晶狀體產品。
根據披露,該產品的開發基於公司牽頭承擔的“十三五”國家重點研發項目“新型人工晶狀體及高端眼科植入材料的研發”內容研究,系可摺疊、疏水性丙烯酸酯、單焦、非球面人工晶狀體,用於矯正白內障超聲乳化手術中無晶狀體眼的視力,在歐盟標準下屬於IIb類醫療器械。該產品採用創新性模注成型生產工藝,即從自有原材料到人工晶狀體晶片一次模注成型,省去中間複雜的車銑牀生產加工流程。該產品於國內屬於第三類醫療器械,相關產品註冊工作已經開展。當前已完成河南省藥品監督管理局的臨牀試驗備案,並已進入臨牀試驗階段。
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