康德萊(603987.SH):一次性使用醫用霧化器獲二類醫療器械註冊證
格隆匯2月21日丨康德萊(603987.SH)公佈,公司全資子公司廣東康德萊醫療器械集團有限公司(“廣東康德萊”)於近日收到廣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》。
註冊證編號:粵械注準20202080152;產品名稱:一次性使用醫用霧化器;型號、規格:K-WH-1(兒童型)、K-WH-2(成人型)結構及組成:產品由杯蓋、杯芯、吸嘴、杯體、導管接頭、導管、調節片、面罩組成。適用範圍:將液態藥物霧化供患者吸入治療用。批准日期:2020年02月04日;有效期至:2025年02月03日。
上述“一次性使用醫用霧化器”適用於將液態藥物霧化供患者吸入治療用,可使用於醫療機構或家庭遵醫囑使用。目前該產品國內市場容量較大,但對於市場推廣尚有一個過程。累計已發生研發投入約為人民幣 42萬元。
截至目前,該產品尚未在國內進行銷售,上述二類醫療器械註冊證的取得,短期內對廣東康德萊及公司的經營業績的影響較小。
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