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Certifications & Compliance


FDA - 510(k) Premarket Notification


FDA
510(k) Database | FDA


Health Canada Medical Devices Active Licence


Health Canada


Intertek Certificate of Registration

Quality Management System - ISO 13485:2016 - MDSAP


Intertek Certificate


CB Test Certificate delivered by TÜV-SÜD

Product was tested and found to be in conformity with:
Certificate by TÜV-SÜD


Certificate delivered by TÜV-SÜD

Product was tested and found to be in conformity with:
Certificate by TÜV-SÜD


Certificate delivered by TÜV-SÜD

Product was tested and found to be in conformity with:
Certificate by TÜV-SÜD


Australian Register of Therapeutic Goods Certificate


Australian Certificate

Australian Certificate