安圖生物(603658.SH)控股子公司取得醫療器械註冊證書
格隆匯12月10日丨安圖生物(603658.SH)公佈,公司控股子公司北京安圖生物工程有限公司(“北京安圖生物”,原北京百奧泰康生物技術有限公司)於近日收到北京市食品藥品監督管理局頒發的《醫療器械註冊證》,產品名稱為二氧化碳(CO2)測定試劑盒(PEPC酶法)。
截至2018年12月31日,二氧化碳(CO2)測定試劑盒(PEPC酶法)累計已發生的研發投入約為40萬元。
根據國家藥品監督管理局官網數據查詢信息,截至公告日,國內外同行業多個廠家已取得上述同類產品的醫療器械註冊證書。例如:西門子、利德曼、華宇億康生物等均擁有同類產品。
上述註冊證的取得,進一步豐富公司產品線,不斷滿足市場需求,是對公司現有產品的有效補充,可以逐步提高公司產品的整體競爭力。2018年公司現有二氧化碳(CO2)測定試劑盒(PEPC酶法)相關同類產品銷售收入約66萬元,佔公司營業收入的比例約0.03%。
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