格隆汇11月5日丨天益医疗(301097.SZ)公布，公司于近日收到欧盟医疗器械法规(Medical Device Regulation (EU) 2017/745，简称"MDR")认证证书。 ...

证书编号：MDR 750054 R000 证券代码： 301097 证券简称：天益医疗 公告编号：2025-056 宁波天益医疗器械股份有限公司 关于公司产品获得欧盟 MDR 认证的公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 宁波天益医疗器械股份有限公司（以下简称"公司"）于近日收到欧盟医疗 器械法规（Medical Device Regulation (EU) 2017/745，简称"MDR"）认证证书， 现将有关情况公告如下： 一、MDR 认证证书的具体情况 证书名称：欧盟质量管理体系证书（EU Quality Management System Certificate） 注册号：CN-MF-000029875 认证产品：Extracorporeal Blood Tubing Set（体外循环血路）、Oral/Enteral Syringe（喂食注射器）、Oral/Enteral Syringe with ENFit connector（带 ENFit 接 头的喂食注射器）、Arterial-Venous Fistula Needle Set（动 ...

Core Insights - The medical device sector experienced a rise of 1.13% on October 31, with Caina Co., Ltd. leading the gains [1] - The Shanghai Composite Index closed at 3954.79, down 0.81%, while the Shenzhen Component Index closed at 13378.21, down 1.14% [1] Medical Device Sector Performance - Caina Co., Ltd. (301122) saw a closing price of 30.38, with a significant increase of 19.98% and a trading volume of 91,000 shares, amounting to a transaction value of 259 million [1] - Spring Medical (688236) closed at 28.88, up 14.47%, with a trading volume of 84,200 shares and a transaction value of 235 million [1] - ZhenDe Medical (603301) closed at 95.00, increasing by 9.07% with a trading volume of 211,900 shares, resulting in a transaction value of 1.951 billion [1] - Other notable performers included TuoJing Life (300642) with an 8.81% increase, and Rejing Bio (688068) with an 8.70% increase [1] Capital Flow Analysis - The medical device sector saw a net inflow of 475 million from institutional investors, while retail investors experienced a net outflow of 108 million [2][3] - Major stocks like Mindray Medical (300760) had a net inflow of 262 million from institutional investors, but a net outflow of 1.27 billion from retail investors [3] - Other stocks such as Furuishi (300049) and Lepu Medical (300003) also showed significant net inflows from institutional investors, indicating strong institutional interest [3]

Market Overview - As of October 27, the Shanghai Composite Index closed at 3996.94 points, with an increase of 1.18% [1] - The Shenzhen Component Index closed at 13489.40 points, up by 1.51% [1] - The ChiNext Index closed at 3234.45 points, rising by 1.98% [1] Trading Activity - A total of 2530 stocks saw an increase in average transaction volume, with 78 stocks experiencing a growth of over 50% [1] - 2034 stocks reported a decrease in average transaction volume [1] - Notable stocks with significant increases in transaction volume include Xinri Co., Haomai Technology, and Changbao Co. [1] Individual Stock Performance - Xinri Co. reported a daily increase of 10.02% with an average transaction volume of 1456 shares, showing a 253.73% increase [1] - Haomai Technology increased by 10.01% with an average transaction volume of 784 shares, reflecting a 206.77% increase [1] - Changbao Co. rose by 9.95% with an average transaction volume of 2716 shares, marking a 197.17% increase [1] - Tianyi Medical saw a significant increase of 20.00% with an average transaction volume of 575 shares, up by 153.85% [1] Active Stocks by Transaction Count - Geer Software had a notable increase in transaction count, rising by 3312.09% with 106,389 transactions [2] - Huajian Group experienced a decrease of 9.99% but had a transaction count increase of 1338.50% with 220,091 transactions [2] - Shanghai Port Bay reported a 1.59% increase with 41,109 transactions, reflecting a 723.50% increase [2] Summary of Notable Stocks - Tianyi Medical, Wanlang Magnetic Plastic, and Jialan Technology all reported significant increases in both transaction volume and count, indicating heightened trading activity [1][2] - Stocks like Xinyuan Co. and Juzhu Co. also showed substantial increases in transaction metrics, suggesting potential investment interest [1][2]

Strong Individual Stocks - As of October 27, the Shanghai Composite Index rose by 1.18% to 3996.94 points, the Shenzhen Component Index increased by 1.51% to 13489.4 points, and the ChiNext Index climbed by 1.98% to 3234.45 points. A total of 64 stocks in the A-share market hit the daily limit up [1] - The top three strong stocks based on consecutive trading days and turnover rate are: - Shilong Industrial (002748) with 5 consecutive limit ups and a turnover rate of 30.47% - Shenkai Co., Ltd. (002278) with 5 limit ups in 6 days and a turnover rate of 57.16% - CITIC Heavy Industries (601608) with 4 limit ups in 6 days and a turnover rate of 9.0% [1] Strong Concept Sectors - The top three concept sectors based on A-share performance are: - Storage Chips with a rise of 3.49% - AI PC with an increase of 3.2% - National Big Fund Holdings with a growth of 3.01% [2][3] - The top ten concept sectors and their respective performance are detailed in the provided table, showcasing various technology and innovation-related sectors [3]

Core Points - Tianyi Medical experienced a trading halt with a daily turnover rate of 23.08% and a transaction volume of 364 million yuan, showing a price fluctuation of 13.78% [2] - The stock was listed on the Shenzhen Stock Exchange due to a closing price increase of 20.00%, with a net selling amount of 24.68 million yuan from brokerage seats [3] - The top five brokerage seats accounted for a total transaction volume of 167 million yuan, with buying transactions amounting to 71.34 million yuan and selling transactions totaling 96.02 million yuan, resulting in a net sell of 24.68 million yuan [3] Trading Data - The largest buying brokerage was Zhongtai Securities with a purchase amount of 17.03 million yuan, while the largest selling brokerage was Zheshang Securities with a selling amount of 32.52 million yuan [3] - The stock saw a net inflow of 14.47 million yuan from main funds, with a significant single net inflow of 16.17 million yuan, while large single funds experienced a net outflow of 1.71 million yuan [3] - Over the past five days, the net inflow of main funds amounted to 10.00 million yuan [3]

Core Viewpoint - Ningbo Tianyi Medical achieved significant growth in revenue and net profit in the first three quarters of 2025, driven by strong sales in blood purification and ward care products [1] Company Performance - The company reported a revenue of 387 million yuan, representing a year-on-year increase of 24.14% [1] - The net profit attributable to shareholders reached 20.09 million yuan, marking a year-on-year growth of 216.81% [1] Industry Environment - The domestic blood purification market is entering a growth phase, with increasing numbers of kidney disease patients and rising reimbursement rates for dialysis costs [2] - The market size of China's blood dialysis industry is projected to grow from 42 billion yuan in 2020 to 73.5 billion yuan in 2024, with a compound annual growth rate of 14.8% [2] Product Competitiveness - The company focuses on technological innovation as a core development driver, establishing a medical extracorporeal circulation blood path engineering center to strengthen its technical advantages in blood purification consumables [2] - Tianyi Medical has developed over 200 specifications of extracorporeal circulation blood path products to meet diverse clinical needs, enhancing market recognition [2] Strategic Initiatives - The company has strategically acquired businesses to fill gaps in its operations and expand its market presence, including a 60 million yuan investment in Ningbo Tianhuiyi and the acquisition of CRRT business from Nikkiso Co., Ltd [3] - The acquisition of BELLCO S.R.L.'s CRRT filter business assets was completed in September, allowing the company to establish a complete CRRT product line and a self-sustaining operational ecosystem for CRRT products [3]

Core Viewpoint - Tianyi Medical (301097.SZ) reported a decline in institutional ownership in its Q3 2025 financial results, with a total of 4 institutional investors holding 1.4158 million shares, representing 2.40% of the total share capital, down by 1.10 percentage points from the previous quarter [1] Institutional Investors - A total of 4 institutional investors disclosed their holdings in Tianyi Medical, with a combined shareholding of 1.4158 million shares [1] - The institutional investors include: - China Merchants Bank Co., Ltd. - Penghua Hongjia Flexible Allocation Mixed Securities Investment Fund - Shanghai Xishirun Investment Management Co., Ltd. - Xishirun Beiyue No. 3 Private Securities Investment Fund - Jiangsu Zhaoxin Private Fund Management Co., Ltd. - Zhaoxin Collective No. 1 Private Securities Investment Fund - Industrial and Commercial Bank of China Co., Ltd. - CITIC Prudential Multi-Strategy Flexible Allocation Mixed Securities Investment Fund (LOF) [1] - The total institutional ownership percentage decreased to 2.40% compared to the previous quarter [1] Public Funds - One new public fund disclosed its holdings this quarter, namely CITIC Prudential Multi-Strategy Mixed (LOF) A [1] - A total of 49 public funds were not disclosed in this quarter compared to the previous quarter, including: - Yuanxin Yongfeng Ju You A - Yuanxin Yongfeng Medical Health A - Nuoan Multi-Strategy Mixed A - Yuanxin Yongfeng Xingyuan A - Penghua Double Bonds Poly Bond B [1]

Core Viewpoint - Tianyi Medical (301097.SZ) reported significant growth in both revenue and net profit for the third quarter of 2025, indicating strong operational performance and potential for continued growth in the healthcare sector [1] Financial Performance - The company achieved a revenue of 160 million yuan in the third quarter, representing a year-on-year increase of 48.03% [1] - Net profit for the third quarter reached 10.61 million yuan, showing a substantial year-on-year growth of 227.86% [1] - For the first three quarters, the company reported a total revenue of 387 million yuan, which is a 24.14% increase compared to the same period last year [1] - The net profit for the first three quarters was 20.09 million yuan, reflecting a year-on-year growth of 216.81% [1]

Group 1 - The core viewpoint of the article highlights Tianyi Medical's strong financial performance in Q3 2025, with significant year-on-year growth in revenue and net profit [1]. - Tianyi Medical reported a revenue of approximately 387 million yuan for the first three quarters of 2025, representing a year-on-year increase of 24.14% [1]. - The net profit attributable to shareholders was around 20.09 million yuan, showing a substantial year-on-year increase of 216.81% [1]. - The basic earnings per share reached 0.34 yuan, which is an increase of 209.09% compared to the previous year [1]. Group 2 - As of the report, Tianyi Medical has a market capitalization of 2.7 billion yuan [2].