Located in Orange County, Southern California – a key hub for medical device innovation – our FDA-registered and inspected facility has been operational since 2012, with registration number 3010052373. We also hold a California State License for the “Manufacturing of Medical Device,” identified by license number 57659.

Committed to excellence, we adhere to current Good Manufacturing Practice (cGMP) standards and are preparing for ISO 13485 certification. Our state-of-the-art facility includes a Class VIII cleanroom, spanning 1,650 square feet, and a dedicated gowning room to maintain the highest cleanliness and precision levels in our production processes. Equipped with advanced automatic production capabilities, we efficiently meet high-demand requirements while maintaining stringent quality control. Our facility features sophisticated video documentation systems, providing transparency and real-time insights into our operations and ensuring the highest standards are met throughout our manufacturing processes.