The kBox4, like previous models, has a European CE Marking Certificate as a Medical Device.
The kBox4 has been assessed to conform with the EU Directive 93/42/EEC regarding medical devices (MDD), Class I, as required by all devices with a medical effect.
What CE Marking is
The CE Marking is a declaration that the product meets the requirements of the applicable European Union Directives, securing free marketability in the European Economic Area.
A CE Marking means that the product meets the essential requirements of all relevant European Medical Device Directives and is a legal requirement to place a device on the market in the European Union.
Certificate of Registration
To download the full Certificate of Registration, click here.