DECLARATIONS OF CONFORMITY
iHealth devices comply with the applicable regulatory requirements and bear the CE marking.
Depending on the product, compliance is established in particular under:
Regulation (EU) 2017/745 on medical devices (MDR);
Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), for devices covered by the applicable transitional provisions ;
Directive 2014/53/EU on radio equipment (RED), for connected devices incorporating a Bluetooth function.
The corresponding declarations of conformity are available on request.
For any enquiries, please contact us at the following address: contact@ihealthlabs.eu