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EC Declaration of Conformity (DoC)

We herewith declare that our products meet the provisions of all applicable EU Directives including the European Committee Council Directive 2014/53/EU on Radio Equipment and its harmonized standards. All supporting documentation are retained under the promises of the manufacturer.

Each Declaration of Conformity is valid in connection with the shipping inspection reports for the respective batch of produced devices. Model and Code are indicated on product rating label.

Blood pressure monitors

RS3 Intelli IT (HEM-6161T-D), RS3 Intelli IT (HEM-6161T-E), RS7 Intelli IT (HEM-6232T-D), RS7 Intelli IT (HEM-6232T-E), HEARTGUIDE (HEM-6411T-MAE), M300 Intelli IT (HEM-7143T1-D), M2 Intelli IT (HEM-7143T1-EBK), X2 Smart (HEM-7143T2-ESL), M400 Intelli IT (HEM-7155T-D), M4 Intelli IT (HEM-7155T-EBK), X4 Smart (HEM-7155T-ESL), MIT5s (HEM-7280T-E), M700 Intelli IT (HEM-7322T-D), M7 Intelli IT (HEM-7322T-E), M500 Intelli IT (HEM-7361T-D), M7 Intelli IT (HEM-7361T-EBK), X7 Smart (HEM-7361T-ESL), EVOLV (HEM-7600T-E), HEM-9210T-E, Nightview (HEM-9601T-E3)

Wheeze monitor

WheezeScan (HWZ-1000T-E)

Pain relievers (TENS)

Avail (HV-F601T-E)

Scales and body composition monitors

VIVA (HBF-222T-EBK), HN300T2 Intelli IT black (HN-300T2-EBK), HN300T2 Intelli IT grey (HN-300T2-EGY)

Blood saturation monitor

P300 Intelli IT (HPO-300T)

Electrocardiograms

Complete (HEM-7530T-E3)

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