鲨纹抗菌医用手套
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【省药监督局】陕西省二类无源医疗器械创新认定实现零的突破
Shan Xi Ri Bao· 2025-08-27 23:00
Core Insights - The establishment of Shaanxi Shanjie Muen Biotechnology Co., Ltd. marks a breakthrough in the recognition of innovative Class II medical devices in Shaanxi Province, with their "single-use sterile micro-structured silicone catheter" being approved by the Shaanxi Provincial Drug Administration [1][2] - The innovative catheter addresses two major clinical issues: urinary tract infections caused by catheters and pain associated with catheter use, utilizing a shark skin micro-structure for antibacterial and pain-reducing effects [1][2] Company Developments - Shaanxi Shanjie Muen Biotechnology Co., Ltd. plans to invest in a national R&D center and an intelligent manufacturing base in Xi'an, which will have an annual production capacity of 10 million shark skin catheters and 1 billion shark skin antibacterial medical gloves [2] - The expected annual output value of the intelligent manufacturing base is projected to reach 954 million yuan, with a profit tax of 455 million yuan [2] Industry Impact - The recognition of innovative Class II passive medical devices in Shaanxi signifies a solid step towards optimizing review processes, encouraging innovation investment, and enhancing industry competitiveness, reflecting a positive interaction between policy guidance and industrial development [2]