Belun team has been awarded worldwide recognitions
Belun’s regulatory strategy in getting its clearance with the US FDA allows us to enter several important markets at an accelerated pace.
U.S. FDA
World 1st FDA 510(k) cleared wearable ring using
Artificial Intelligence
for Obstructive Sleep Apnea diagnosis with sleep stages
ISO Certification
ISO 13485 medical devices quality management system
Malaysia FDA
Malaysia MDA medical-grade wearable
Taiwan FDA
Taiwan FDA Class II medical-grade wearable
FDA Thailand
FDA Thailand Class III medical-grade wearable
If you are also interested in medical technological innovation
