康德萊(603987.SH):浙江康德萊完成醫療器械生產許可證變更登記
格隆匯3月23日丨康德萊(603987.SH)公佈,上海康德萊企業發展集團股份有限公司全資子公司浙江康德萊醫療器械股份有限公司(以下簡稱“浙江康德萊”)於近日取得浙江省藥品監督管理局核發的《准予行政許可決定書》,同意浙江康德萊生產範圍以及生產產品的變更。本次變更涉及《醫療器械生產許可證》及《醫療器械生產產品登記表》,《醫療器械生產許可證》登記信息變更前後的具體內容。
變更後生產範圍為:第二、三類6815注射穿刺器械;第三類6866醫用高分子材料及製品;第二類6841醫用化驗和基礎設備器具;Ⅱ類:14-01-注射、穿刺器械,14-02-血管內輸液器械,17-04-口腔治療器具;Ⅲ類:10-02-血液分離、處理、貯存器具,14-01-注射、穿刺器械,14-02-血管內輸液器械,22-11-採樣設備和器具,08-02-麻醉器械。發證部門變更為浙江省藥品監督管理局。
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