EC DECLARATIONS OF CONFORMITY
All our medical devices comply with current European regulations (Directive 93/42/EEC for medical devices and Directive 98/79/EC for in vitro diagnostic devices). Our blood pressure monitors are also approved by ESH (European Society of Hypertension) and our blood glucose meters comply with the requirements of ISO15197: 2015.
All our medical devices are regulated and carry the CE mark. Declaration of conformity for medical devices can be downloaded below:
iHealth Track, Sense, View, Feel, Neo, Ease et Clear