陽普醫療(300030.SZ):子公司醫療器械註冊證變更
格隆匯 10 月 23日丨陽普醫療(300030.SZ)公佈,近日,公司全資子公司廣州瑞達醫療器械有限公司(“廣州瑞達”)收到了由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變更文件》,具體情況如下:
產品名稱:電子直乙腸內窺鏡;註冊證編號:國械注準20183220068;批准日期:2020年9月30日
變更內容:
1、為滿足市場需求,增加型號IRE101AIRE200A。產品型號由“IRE100A”變更為“IRE100AIRE101AIRE200A”。
2、適用範圍由“該產品與廣州瑞達生產的電子直乙腸鏡配套主機及廣州陽普醫療科技股份有限公司生產的IRE100T型一次性內窺鏡保護套配合使用。”變更為“該產品與廣州瑞達生產的電子直乙腸鏡配套主機及廣州陽普醫療科技股份有限公司生產的IRE100T、IRE100T-A、IRE200T型一次性內窺鏡保護套配合使用。”
3、註冊證產品技術要求發生變更。
備註:按新的《分類目錄》,該產品分類編碼為06,管理類別為三類。本文件與“國械注準20183220068”註冊證共同使用。
此次註冊變更後,電子直乙腸內窺鏡的產品型號增加了體檢簡化版本和高清高精度版本,能夠滿足不同醫療機構的檢查需求,形成了產品系列化、差異化,增加了產品競爭力,有助於增強產品差異化競爭的銷售能力,對公司未來的經營將產生積極影響。
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.