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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 (Polish Centre for Testing and Calibration, NB No. 1434) allowing free movement and sale throughout the European Economic Area.

The device is also approved by the Saudi Food and Drug Authority and the Singaporean Health Sciences Authority.

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

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