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三鑫醫療(300453.SZ):獲醫療器械註冊證 涉及密閉式靜脈留置針
格隆匯 01-20 19:57

格隆匯1月20日丨三鑫醫療(300453.SZ)公佈,公司於近日取得國家藥品監督管理局(“國家藥監局”)頒發的《醫療器械註冊證》,產品名稱為密閉式靜脈留置針。

與公司此前已經獲得註冊證的一次性使用靜脈留置針、正壓靜脈留置針不同,公司本次新研發完成並取得註冊證的密閉式靜脈留置針的導管和軟管採用了聚氨酯材料替代聚氯乙烯(PVC)材料,且不含鄰苯二甲酸二(2-乙基)己酯(DEHP)增塑劑,聚氨酯材料具有優良的抗凝血性能,臨牀應用中生物相容性好,無致畸變作用、無過敏反應,並具有優良的韌性和彈性等加工性能。

公司此次獲得密閉式靜脈留置針醫療器械註冊證,進一步豐富了公司留置介入系列產品的種類,有利於公司以更全面的產品組合參與全國範圍正在陸續開展的醫用耗材“帶量採購”,將進一步提升公司的核心競爭力與市場拓展能力,有利於公司為更多患者提供更優質的醫療產品和服務,對公司未來發展將產生積極影響。

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