科華生物(002022.SZ)子公司取得醫療器械生產許可證
格隆匯12月12日丨科華生物(002022.SZ)公佈,近日,公司全資子公司上海科華實驗系統有限公司陝西分公司收到陝西省藥品監督管理局頒發的《醫療器械生產許可證》(許可證編號:陝食藥監械生產許20190036號)。
產品名稱1:全自動生化分析儀;註冊號陝械注準20192220087;登載日期2019-11-22;
產品名稱2:全自動化學發光免疫分析儀;註冊號陝械注準20192220088;登載日期2019-11-22。
此次取得的《醫療器械生產許可證》進一步豐富了公司診斷儀器產品線,公司自主研發的Polaris系列全自動生化分析儀和全自動化學發光免疫分析儀獲得生產許可批准,將有助於新產品上市拓展,提升公司在IVD領域的綜合競爭實力。
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