開立醫療(300633.SZ):電子下消化道內窺鏡取得醫療器械註冊證
格隆匯1月5日丨開立醫療(300633.SZ)公佈,公司的一種醫療器械產品已獲廣東省藥品監督管理局批准,於近日取得中華人民共和國醫療器械註冊證,產品名稱為電子下消化道內窺鏡。臨牀用途:與公司生產的醫用內窺鏡圖像處理器(型號:HD-550、HD-550Exp、HD-550Pro、HD-550S、HD-510、HD-500Plus)配合使用,用於通過視頻顯示器提供影像供下消化道(包括肛門、直腸、結腸、回盲部)觀察、診斷和治療。
可變焦內鏡用來觀察消化道黏膜表面腺管開口、微血管及毛細血管等微細結構的改變,有利於判斷黏膜病變的病理學性質,明確病變浸潤範圍及提高活檢準確性,在消化道疾病尤其是早期腫瘤診斷方面有獨特優勢。
公司推出的可變焦內鏡EC-550Z,具備光學放大功能,實現對3mm物距內的病灶細節進行放大觀察。可以實現85倍的圖像放大倍率,同時結合公司光源的SFI、VIST特殊光染色光模式,可以讓醫生觀察清楚的黏膜表面、粘膜下層毛細血管形態和腺管開口形態,從而初步判斷早癌的性質,臨牀意義極大。
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