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康德萊(603987.SH):控股子公司產品獲得二類醫療器械註冊證
格隆匯 07-10 16:09

格隆匯 7 月 10日丨康德萊(603987.SH)公佈,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》。

醫療器械註冊證的具體情況:

註冊證編號:滬械注準20202180314

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:輸卵管導管套件

結構及組成:產品有3種組合,1)由導引導管、造影導管、指引導絲和造影導絲四個組件組合而成,2)由導引導管、指引導絲二個組件組合而成,3)由造影導管、造影導絲二個組件組合而成。其中導引導管和造影導管均由導管座、導管護套、主體導管組成,指引導絲和造影導絲均由芯絲和繞絲組成。適用範圍:供醫療機構通過宮腔鏡操作通道或其他子宮介入器械通道插入輸卵管,注入色素液或造影劑來評估輸卵管的通暢性,並進行注液疏通操作。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07月07日

有效期至:2025年07月06日

上述“輸卵管導管套件”產品累計已發生研發投入約為人民幣100萬元。目前國內市場上同類產品外資品牌的市場佔比較高,且產品價格偏高,臨牀可選擇性小。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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