夢潔股份(002397.SZ)取得醫療器械生產許可證及醫療器械註冊證
格隆匯3月19日丨夢潔股份(002397.SZ)公佈,公司於近日取得了湖南省藥品監督管理局頒發的《醫療器械生產許可證》和《中華人民共和國醫療器械註冊證》。其中,《醫療器械生產許可證》生產範圍:Ⅱ類:14-14醫護人員防護用品,有效期限:至2025年3月12日。《中華人民共和國醫療器械註冊證》涉及產品名稱為一次性醫用口罩(非無菌型),一次性醫用口罩(無菌型)及醫用防護服(無菌型)。
為了抗擊新型冠狀病毒疫情,保障防疫物資的供應。2020年2月9日,公司被湖南省新型冠狀病毒感染疫情防控工作領導小組防疫物資保障組列為《第六批疫情防控期間省重點聯繫企業名單》,重點產品為口罩。按照政府相關部門的指導和協調,公司積極進行防疫物資的生產籌備工作。
截止目前,公司已取得了《醫療器械生產許可證》和《中華人民共和國醫療器械註冊證》。公司1條醫用口罩生產線已正式投產,日產能4萬隻;已改造部分家紡生產線生產醫用防護服,日產能1,000套。公司另外簽訂的2條醫用口罩生產線,1條生產線預計在3月25日前交付公司安裝調試;1條生產線因為產品技術原因,確認無法交付,公司後續將根據實際需求確定是否採購新的醫用口罩生產線。
公司目前生產的醫用口罩及防護服優先政府部門統一調配,如有剩餘公司將對外銷售。
公司醫用口罩及防護服預計產生的收入佔公司全年營業收入的比重很小,對公司的經營業績不會產生重大影響,敬請投資者注意投資風險。
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