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云南省药品监督管理局关于2025年医疗器械质量监督抽检结果通告(2025年第1期)
Zhong Guo Zhi Liang Xin Wen Wang· 2025-09-11 04:42
Core Points - The Yunnan Provincial Drug Administration conducted quality supervision and spot checks on 294 batches of medical devices, with all inspection results meeting regulations [1][2][3] Group 1: Inspection Results - All 294 batches of medical devices inspected were found to comply with the relevant standards [1] - Specific products inspected included disposable nasal oxygen tubes, infusion sets, sterile syringes, and surgical gloves, all of which passed the quality checks [1][2][3] Group 2: Product Details - Notable products included: - Disposable nasal oxygen tubes from Henan Tuo Ren Best Medical Devices Co., Ltd. and Jiangxi Jingkangyu Medical Technology Co., Ltd. [1] - Disposable infusion sets from Shandong Weigao Group Medical Polymer Co., Ltd. and Jiangxi Hongda Medical Devices Group Co., Ltd. [1][2] - Sterile syringes from Yunnan Haodi Medical Devices Co., Ltd. [1] - Surgical gloves from Shanghai Kebo Medical Latex Products Co., Ltd. [1][2][3] Group 3: Regulatory Compliance - The inspections were conducted in accordance with the "Medical Device Supervision and Administration Regulations" and the "2025 Yunnan Province Medical Device Supervision and Spot Check Work Plan" [1] - The results indicate a strong compliance rate among medical device manufacturers in Yunnan Province [1][2]