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].
天益医疗涉嫌违规生产三类医疗器械拟被罚没1401万元