康德萊(603987.SH):“一次性使用指引導管”獲三類醫療器械註冊證
格隆匯12月19日丨康德萊(603987.SH)公佈,公司控股子公司上海康德萊醫療器械股份有限公司(以下簡稱“康德萊醫械”)於近日收到國家藥品監督管理局頒發的《中華人民共和國醫療器械註冊證》。
“一次性使用指引導管”適用於經皮冠狀動脈成形術為介入器械和診斷器械的導入提供通道。累計已發生研發投入約為人民幣180萬元。目前國內市場外資品牌的銷售佔比較高。
上述三類醫療器械註冊證的取得,是對康德萊醫械現有介入類產品線的有效補充,進一步提高康德萊醫械核心競爭力,對康德萊醫械在介入治療領域發展和市場拓展具有積極意義。截止目前,該產品尚未在國內進行銷售,短期內對康德萊醫械及公司的經營業績的影響較小。
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