CardioGraphe is cleared for distribution by regulatory authorities in the USA, EU 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.
CardioGraphe is not available in all markets.