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©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

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

Artificial Intelligence

for Obstructive Sleep Apnea diagnosis with sleep stages

ISO Certification

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ISO 13485 medical devices quality management system

Malaysia FDA

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Malaysia MDA medical-grade wearable

Taiwan FDA

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Taiwan FDA Class II  medical-grade wearable

FDA Thailand

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FDA Thailand Class III medical-grade wearable

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