CE Marking

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.



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