You are browsing the Hong Kong website, Regulated by Hong Kong SFC (CE number: BJA907). Investment is risky and you must be cautious when entering the market.
康德萊(603987.SH):一次性使用微導管獲得三類醫療器械註冊證
格隆匯 12-31 15:39

格隆匯 12 月 31日丨康德萊(603987.SH)公佈,公司控股子公司上海璞慧醫療器械有限公司(“璞慧醫療”)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》。

註冊證編號:國械注準20203030984;產品名稱:一次性使用微導管;結構及組成:一次性使用微導管由導管、導向鞘、護套、導管座、顯影環和護套管組成。產品經環氧乙烷滅菌,一次性使用。貨架有效期3年。適用範圍:適用於神經血管和外周血管,用於注射或輸入對照介質和/或液體和/或栓塞材料,和/或適當的器械(如支架、彈簧圈)等。批准日期:二〇二〇年十二月十七日;有效期至:二〇二五年十二月十六日。

上述“一次性使用微導管”累計已發生研發投入約為人民幣114萬元,目前國內市場外資品牌銷售佔比較高。

上述醫療器械註冊證為璞慧醫療獲批的首張產品註冊證(三類),該註冊證的取得將進一步提高璞慧醫療核心競爭力,對其在介入治療領域的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,短期內對璞慧醫療及公司的經營業績影響較小。

Follow us
Find us on Facebook, Twitter , Instagram, and YouTube or frequent updates on all things investing.Have a financial topic you would like to discuss? Head over to the uSMART Community to share your thoughts and insights about the market! Click the picture below to download and explore uSMART app!
Disclaimers
uSmart Securities Limited (“uSmart”) is based on its internal research and public third party information in preparation of this article. Although uSmart uses its best endeavours to ensure the content of this article is accurate, uSmart does not guarantee the accuracy, timeliness or completeness of the information of this article and is not responsible for any views/opinions/comments in this article. Opinions, forecasts and estimations reflect uSmart’s assessment as of the date of this article and are subject to change. uSmart has no obligation to notify you or anyone of any such changes. You must make independent analysis and judgment on any matters involved in this article. uSmart and any directors, officers, employees or agents of uSmart will not be liable for any loss or damage suffered by any person in reliance on any representation or omission in the content of this article. The content of the article is for reference only and does not constitute any offer, solicitation, recommendation, opinion or guarantee of any securities, virtual assets, financial products or instruments. Regulatory authorities may restrict the trading of virtual asset-related ETFs to only investors who meet specified requirements. Any calculations or images in the article are for illustrative purposes only.
Investment involves risks and the value and income from securities may rise or fall. Past performance is not indicative of future performance. Please carefully consider your personal risk tolerance, and consult independent professional advice if necessary.
uSMART
Wealth Growth Made Easy
Open Account