一次性使用无菌导尿管获批上市

Core Viewpoint - The National Medical Products Administration has approved the registration application for a new innovative product, a "single-use sterile urinary catheter," developed by Taizhou Dubomai Medical Devices Co., Ltd [1] Group 1: Product Details - The urinary catheter is available in single-lumen, double-lumen, and triple-lumen types [1] - The catheter's outer surface is coated with polylysine, which utilizes the charge interaction mechanism between polylysine and bacterial cell membranes to exert antibacterial effects [1] - This design aims to reduce bacterial colonization and growth on the catheter surface through direct contact [1] Group 2: Regulatory Oversight - The drug supervision authority will enhance post-market surveillance of the product to ensure patient safety when using the device [1]