Behind the superior quality lies Germe's "full-dimensional compliance certification system." The company has not only passed dual certifications of ISO13485 medical device quality management system and ISO9001 quality management system, but also holds a national Class II medical device production license and product registration certificate, in addition to US FDA 510K and EU CEMDR international certifications, forming a compliance barrier covering both domestic and international markets to ensure that products meet stringent global standards. Supporting this system is a core R&D team of over 20 people, multiple patented technologies, and a large-scale manufacturing capacity of 5 production lines, 5,300 square meters of production space, and over 2 million units per year, ensuring product stability throughout the entire process from R&D to production.