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ISO 13485:2016

FOBI Medical is committed to the highest level of quality and safety.  As such, we have implemented ISO 13485:2016 Medical devices – Quality management systems.  We are audited by an external organization to ensure our compliance, reliability and to better satisfy the needs of our customers.

ISO 13485:2016 Certificate

FDA Registration

FOBI Medical is registered with the US Food & Drug Administration (FDA).  

Establishment Registration & Device Listing