Core Viewpoint - Tianyi Medical (301097.SZ) experienced a significant stock decline of 6.87%, reaching a new low of 51.1 yuan since October 28, due to administrative penalties imposed by the Ningbo Market Supervision Administration for production violations related to medical devices [1] Regulatory Actions - Tianyi Medical received an administrative penalty notice for allegedly failing to produce a Class III medical device, specifically a blood purification device, according to registered technical requirements [1] - The Ningbo Market Supervision Administration plans to impose penalties based on the Administrative Penalty Law of the People's Republic of China, considering Tianyi Medical's cooperation during the investigation and proactive measures taken [1] Penalty Details - The proposed penalties include the confiscation of 7,170 sets of illegally produced medical devices, the confiscation of illegal gains amounting to 5,232,711.60 yuan, and a fine of 8,785,180.72 yuan [1]

Core Viewpoint - Tianyi Medical (301097.SZ) has received an administrative penalty notice from the Ningbo Market Supervision Administration for allegedly failing to produce medical devices according to registered technical requirements, which may lead to significant financial penalties and operational adjustments [1][2]. Group 1: Administrative Penalty Details - The company was notified on December 19, 2025, regarding the administrative penalty for not adhering to the registered technical requirements for the production of blood purification devices [1]. - The investigation concluded that Tianyi Medical produced blood pathway products that did not comply with the registered specifications, violating the Medical Device Supervision and Administration Regulations [2]. - The proposed penalties include the confiscation of 7,170 sets of illegally produced medical devices and a fine totaling approximately 8.79 million yuan, along with the confiscation of illegal gains amounting to about 5.23 million yuan [2]. Group 2: Financial Impact - The total financial penalty for Tianyi Medical amounts to approximately 14.02 million yuan [3]. - The company went public on April 7, 2022, with an initial share price of 52.37 yuan, raising a total of approximately 77.18 million yuan in its IPO [3][4]. - The net proceeds from the IPO were about 69.46 million yuan, which was higher than the initially planned amount by approximately 18.45 million yuan [4].

Core Viewpoint - Tianyi Medical is facing a proposed administrative penalty of approximately 14.01 million yuan due to violations in the production of Class III medical devices, specifically blood purification devices, as per the Ningbo Market Supervision Administration's notice [1][2]. Group 1: Administrative Penalty Details - Tianyi Medical received an administrative penalty notice on December 19, indicating that it failed to produce blood purification devices according to registered technical requirements, which constitutes a violation of the Administrative Penalty Law of the People's Republic of China [1]. - The proposed penalties include the confiscation of 7,170 sets of illegally produced medical devices, confiscation of illegal gains amounting to 5.23 million yuan, and a fine of 8.79 million yuan, totaling approximately 14.01 million yuan [2]. Group 2: Company Operations and Financial Performance - Despite the ongoing administrative penalty proceedings, Tianyi Medical reported that its production and operational activities remain normal and orderly as of the announcement date [2]. - For the first three quarters of 2025, Tianyi Medical achieved a revenue of 387 million yuan, representing a year-on-year increase of 24.14%. The net profit attributable to shareholders was 20.09 million yuan, up 216.81%, while the net profit excluding non-recurring items reached 8.41 million yuan, reflecting a significant increase of 762.11% [3]. - The company anticipates that the administrative penalty will have a substantial negative impact on its performance for the year 2025 [3].

2025年12月24日，天益医疗（SZ301097，前收盘价54.87元，市值32.35亿元）发布公告称，因涉嫌未按 照经注册的产品技术要求组织生产第三类医疗器械血液净化装置的体外循环血路产品，公司收到宁波市 市场监督管理局下发的《行政处罚告知书》，拟被没收违法生产的医疗器械、违法所得及罚款，合计金 额约1401.79万元。这一事件引发了市场的广泛关注。 涉案的血液净化装置体外循环血路产品，是患者血液净化过程中的关键设备，属于国家重点监管的高风 险第三类医疗器械。然而，天益医疗却为了迎合市场需求和适配临床机型，公然违反《医疗器械监督管 理条例》，生产了7170套与注册技术要求不一致的产品。这种对法规的无视，不仅是对市场规则的践 踏，更是对患者生命的漠视！ 尽管公司在案发后采取了召回和整改措施，但这种"先违规、后补救"的行为，无法掩盖其在生产管理上 的严重失职。违法生产的每一套医疗器械都可能成为患者生命安全的隐患，天益医疗作为一家专注于医 疗器械研发和生产的企业，本应将质量和安全放在首位，却因迎合市场需求而忽视法规要求，这种短视 行为不仅损害了公众利益，也严重破坏了企业的声誉和形象。 天益医疗需要深刻反思此次事 ...

Core Viewpoint - Tianyi Medical has been penalized for producing medical devices that did not comply with registered technical requirements, resulting in the confiscation of 7,170 sets of illegal products and a fine of 14.02 million yuan [1][2]. Group 1: Regulatory Issues - The company was found to have produced blood purification devices that did not meet the specified technical requirements, violating the Medical Device Supervision and Administration Regulations [2]. - The Ningbo Market Supervision Administration noted that the involved products are classified as high-risk medical devices and require strict management [1]. Group 2: Company Response and Penalties - Tianyi Medical cooperated with the investigation, recalled some of the involved products, and implemented corrective measures, which led to a reduction in penalties [2]. - The penalties imposed include the confiscation of 7,170 illegal medical devices, confiscation of illegal gains amounting to 5.23 million yuan, and a fine of 8.79 million yuan [2]. Group 3: Financial Performance - For the first three quarters of the year, the company reported a revenue of 387 million yuan, representing a year-on-year increase of 24.14% [3]. - The net profit attributable to the parent company was 20.09 million yuan, showing a significant year-on-year growth of 216.81% [3]. - The net profit after deducting non-recurring gains and losses reached 8.41 million yuan, with a remarkable increase of 762.11% year-on-year [3]. Group 4: Market Performance - On December 24, Tianyi Medical's stock price increased by 0.48%, closing at 54.87 yuan per share, with a total market capitalization of 3.234 billion yuan [4].

Core Viewpoint - Tianyi Medical has received an administrative penalty notice from the Ningbo Market Supervision Administration due to alleged violations in the production of Class III medical devices, specifically blood purification devices [1] Summary by Relevant Categories Administrative Penalty - The company is facing administrative penalties that include the confiscation of 7,170 sets of illegally produced medical devices [1] - The company will also have to forfeit illegal gains amounting to 5.2327 million yuan [1] - A fine of 8.7852 million yuan has been imposed on the company [1]

Core Viewpoint - Tianyi Medical (301097.SZ) has received an administrative penalty notice from the Ningbo Market Supervision Administration for allegedly failing to produce a Class III medical device, a blood purification device, according to registered technical requirements [1] Group 1: Administrative Penalty Details - The company is facing administrative penalties due to non-compliance with production regulations for medical devices [1] - The Ningbo Market Supervision Administration plans to confiscate 7,170 sets of illegally produced medical devices and 5,232,711.60 yuan of illegal gains [1] - A fine of 8,785,180.72 yuan is also proposed as part of the administrative penalty [1] Group 2: Mitigating Factors - Tianyi Medical has cooperated with the investigation, provided evidence, and implemented risk control measures, including recalling some involved products [1] - The company is being considered for a reduced penalty due to its proactive response and the fact that this is its first violation [1]

Group 1 - The company Tianyi Medical (301097.SZ) received an administrative penalty notice from the Ningbo Market Supervision Administration for allegedly failing to produce Class III medical devices, specifically blood purification devices, according to registered technical requirements [1] - The proposed penalties include the confiscation of 7,170 sets of illegally produced medical devices, confiscation of illegal gains amounting to 5.2327 million yuan, and a fine of 8.7852 million yuan [1]

证券代码： 301097 证券简称：天益医疗 公告编号：2025-067 宁波天益医疗器械股份有限公司 关于公司收到宁波市市场监督管理局《行政处罚告知书》 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"天益医疗"或"公司")于 2025 年 12 月 19 日收到宁波市市场监督管理局（以下简称"宁波市市监局"或"本局"） 下发的《行政处罚告知书》（甬市监罚告（2025）28 号），因公司涉嫌未按照 经注册的产品技术要求组织生产第三类医疗器械血液净化装置的体外循环血路， 依据《中华人民共和国行政处罚法》第四十四条的规定，宁波市市监局拟对公司 作出行政处罚，现将主要内容公告如下： 一、《行政处罚告知书》主要内容 宁波天益医疗器械股份有限公司： 由本局立案调查的天益医疗涉嫌未按照经注册的产品技术要求组织生产第 三类医疗器械血液净化装置的体外循环血路（以下简称"血路产品"）一案，已 调查终结。依据《中华人民共和国行政处罚法》第四十四条的规定，现将本局拟 作出行政处罚的内容及事实、理由、依据告知如下： 本案所涉血路产品供 ...

登录新浪财经APP 搜索【信披】查看更多考评等级 证券代码：301097 证券简称：天益医疗 公告编号：2025-065 宁波天益医疗器械股份有限公司 第四届董事会第一次会议决议公告 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。 一、董事会会议召开情况 宁波天益医疗器械股份有限公司(以下简称"公司")第四届董事会第一次会议通知于2025年12月9日以电 话、短信、电子邮件等方式向公司全体董事发出。会议于2025年12月12日上午10:00在公司会议室召 开。 本次会议应参会董事7名，实际参会董事7名。会议由董事长吴志敏先生召集和主持，部分高管列席了会 议。本次会议的召集、召开及表决程序符合有关法律、行政法规、部门规章、规范性文件及《公司章 程》的规定。 二、董事会会议审议情况 经与会董事审议，审议结果如下： 1、审议通过了《关于选举第四届董事会董事长的议案》 同意选举吴志敏先生为公司第四届董事会董事长。董事长任期为本次董事会审议通过之日起至第四届董 事会任期届满之日止。 具体内容详见同日在中国证监会指定创业板信息披露网站巨潮资讯网上发布的相关公告。 表决结果 ...