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Certification

CAERvest® meets certification requirements for the Conformité Européenne (CE) Mark as a Class IIa medical device. The device is authorised by a Notified Body (Underwriters Laboratories, 0843) allowing free movement and sale throughout the European Economic Area.

The device has SFDA approval and the FCC Declaration of Conformity is currently being sought prior to going on sale in the United States.

The Company operates a Quality Management System (QMS) aligned with the requirements of ISO 13485 for medical devices.

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