Scroll to top
©2021-2023 Belun Technology


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

FDA_510k_cleared_word

World 1st FDA 510(k) cleared wearable ring using

Artificial Intelligence

for Obstructive Sleep Apnea diagnosis with sleep stages

ISO Certification

ISO13485_certno

ISO 13485 medical devices quality management system

Malaysia FDA

mda_logo

Malaysia MDA medical-grade wearable

Taiwan FDA

TFDA_class_II

Taiwan FDA Class II  medical-grade wearable

FDA Thailand

FDA_Thailand

FDA Thailand Class III medical-grade wearable

If you are also interested in medical technological innovation