宁夏回族自治区药品监督管理局关于2025年100批次医疗器械质量抽检信息的通告

Core Viewpoint - The Ningxia Hui Autonomous Region Drug Supervision Administration announced the results of the 2025 medical device quality sampling inspection, revealing that out of 100 batches tested, 98 were qualified and 2 were unqualified, leading to regulatory actions against the non-compliant products [2]. Group 1: Inspection Results - A total of 100 batches of medical devices were sampled in 2025, covering 32 categories including customized dentures and disposable medical masks [2]. - 98 batches passed the quality inspection, while 2 batches were found to be non-compliant [2]. - Regulatory measures such as sealing, confiscation, and suspension of sales were implemented for the non-compliant medical devices [2]. Group 2: Specific Products - The inspection included various products such as surgical masks, dental devices, and infusion sets, with detailed results provided for each [2][3]. - Specific products that failed the inspection included a type of surgical mask from Henan Laige Medical Technology Co., Ltd., which was deemed non-compliant [2]. - Other products, such as a hand-cranked hospital bed and a disposable infusion set, were found to be compliant [2][3].