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.
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ISO 13485 Medical Devices Quality Management System (MD676399)
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US FDA 510(k) Cleared Wearable Ring Using Artificial Intelligence for Obstructive Sleep Apnea Diagnosis with Sleep Stages
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Malaysia MDA Medical-grade Wearable
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Taiwan FDA Class II Medical-grade Wearable
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FDA Thailand Class III Medical-grade Wearable
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India CDSCO Class B AI-based OSA Diagnosis Sleep System
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