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康德萊(603987.SH):“關節鏡用腕管鬆解手術器械”獲得二類醫療器械註冊證
格隆匯 09-28 15:35

格隆匯 9 月 28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(“康德萊醫械”)於近日收到上海市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:滬械注準20202040468;註冊人名稱:上海康德萊醫療器械股份有限公司;註冊人住所:上海市嘉定區金園一路925號2幢;生產地址:上海市嘉定區金園一路925號;產品名稱:關節鏡用腕管鬆解手術器械;型號、規格:LRK01、LRK02、LRK03、LRK04;結構及組成:產品由擴張器、帶撐芯套管、剝離器、勾刀和剷刀組成,塑料部分採用丙烯腈-丁二烯-苯乙烯共聚物(ABS)PA-747製成,金屬部分採用420J2不鏽鋼製成。適用範圍:用於在關節鏡下作腕管鬆解手術。其他內容:產品採用環氧乙烷滅菌,無菌提供,一次性使用。產品有效期3年。批准日期:2020年09月25日有效期至:2025年09月24日。

上述“關節鏡用腕管鬆解手術器械”產品累計已發生研發投入約為人民幣300萬元,目前國內市場暫無同款一次性使用產品。

上述二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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