新華醫療(600587.SH):2項產品獲得二類醫療器械註冊證
格隆匯11月24日丨新華醫療(600587.SH)公佈,公司於近日收到山東省藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》,具體情況如下:
(一)產品名稱:多艙式全自動清洗消毒器;結構及組成:產品主要由前車、清洗艙、超聲艙(若有)、消毒艙、乾燥艙、管路系統、控制系統、清洗車及傳送軌道組成;適用範圍:產品主要用於對手術器械、玻璃器皿、麻醉器械、塑料製品的清洗消毒和乾燥。
(二)產品名稱:血清澱粉樣蛋白 A檢測試劑盒(乾式免疫熒光法);預期用途:用於體外定量測定人全血、血漿、血清中血清澱粉樣蛋白A(SAA)的含量。
多艙式全自動清洗消毒器為新華醫療清洗消毒設備的高端產品,它的成功研發上市,實現了高端清洗消毒設備國產化,進一步豐富了新華醫療感控的清洗消毒產品系列,鞏固和提升了感控產品的市場佔有率及核心競爭力。血清澱粉樣蛋白A檢測試劑盒(乾式免疫熒光法)的批准上市進一步豐富了公司體外診斷試劑產品線,是對熒光免疫層析產品的有效補充,為客户提供多種選擇,進一步提升公司產品競爭力。
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