Regulatory

CardioGraphe is cleared for distribution by regulatory authorities in the USA, EU, China and other countries.

Arineta is ISO13485:2016 certified.

CardioGraphe is CSA approved.

CardioGraphe complies with the performance standards of 21 CFR, sub-chapter J, the applicable IEC 60601-1 series, NEMA XR-25, XR-26, XR-28 and XR29.

CardioGraphe is a CE-compliant device.