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Our Quality System has been certified to conform to ISO 13485:2003 Medical Device Quality Management Standard. Certificate Number 2111770 endorsed by KEMA Quality B.V. All of our medical devices are also CE Mark certified. Endorsed by KEMA Quality B.V., CE 0344.
Additionally, our devices are registered as Device Class 2, with the Medical Devices Bureau of the Therapeutic Products Directorate of Health Canada. Manufacturer ID: 117097.
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