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Regulatory Approvals, Clearances and Quality Certificates

FDA 510(k) Clearance August 2022

FDA 510(k) Clearance July 2020

FDA 510(k) Clearance December 2016

FDA 510(k) Clearance February 2016

FDA 510(k) Clearance February 2015

ISO 13485: 2016 MDSAP Certification

EN ISO 13485:2016 Certification

CE Marking

Canada Medical License

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