Core Viewpoint - Tianyi Medical, a manufacturer of blood purification consumables, faces administrative penalties from the Ningbo Market Supervision Administration for producing medical devices that do not comply with registered technical requirements, with total penalties amounting to approximately 14.0179 million yuan [1][2]. Group 1: Regulatory Actions - The Ningbo Market Supervision Administration issued an administrative penalty notice to Tianyi Medical for failing to produce blood purification devices according to registered technical specifications, which constitutes a violation of the Medical Device Supervision and Administration Regulations [1]. - The penalties include the confiscation of 7,170 sets of illegally produced medical devices, the confiscation of illegal gains amounting to 523.27 million yuan, and a fine of 878.52 million yuan [2]. Group 2: Company Overview - Tianyi Medical specializes in the research, production, and sales of medical polymer consumables in the fields of blood purification and ward care, with key products including blood purification devices, disposable venous and arterial puncture devices, and blood dialysis concentrates [2]. - For the first three quarters of 2025, Tianyi Medical reported a revenue of 387 million yuan, representing a year-on-year increase of 24.14%, and a net profit attributable to shareholders of 20.0941 million yuan, up 216.81% year-on-year [2]. Group 3: Operational Status - Tianyi Medical stated that the regulatory issues will not lead to a situation that triggers mandatory delisting, and the company's production and operations remain normal [3].
涉嫌违规生产三类医疗器械 天益医疗遭行政处罚