Regulatory

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.

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