天益醫療(301097.SZ):首次獲得血液透析濃縮液醫療器械註冊證
格隆匯2月3日丨天益醫療(301097.SZ)公佈,公司於近日收到國家藥品監督管理局頒發的《醫療器械註冊證》。產品名稱:血液透析濃縮液;註冊類別:Ⅲ;預期用途:用於急、慢性腎功能衰竭患者的血液透析治療。
公司本次獲得醫療器械註冊證的血液透析濃縮液由A濃縮液(簡稱""A液)和B濃縮液(簡稱"B液")組成。A液由氯化鈉、氯化鉀、氯化鈣、氯化鎂、枸櫞酸和透析用水組成,B液由碳酸氫鈉和透析用水組成。該產品使用枸櫞酸作為pH調節劑,其糾正酸中毒效果明顯,生物相容性較好,具有良好的抗凝作用,有利於保持透析器中空纖維和膜孔的通透性,改善透析效果,提高透析質量,符合臨牀個性化透析的需求。
公司表示,此次是公司首次獲得血液透析濃縮液的醫療器械註冊證,該註冊證的取得進一步延長了公司產品鏈,豐富了公司產品類別,有利於提高公司綜合競爭力。
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