New Achievements Achieved · OTC and Prescription Dual Use Integration Application Project Passed Defects

The OTC and prescription FDA 510K dual-use integration application project submitted by Shenzhen Ruienni Medical Device Management Consulting Co., Ltd. on August 1, 2019 was approved with zero defects on November 1, 2019, and took 3 months to be submitted for approval. This is our fourth case in two years to receive approval for 510K zero defects. This not only represents an honor, but also a strength. During 2019, we have continuously represented clients in submitting over 20 510K registration projects. Because of focus, it is professional; Excellence is due to professionalism; Because of excellence, leading.