Approvals and cerifications

CE Certified according to: 

EU regulation 2017/745 MDR on medical devices, LVFS 2003: 11,
LVFS 2001: 7. Reg no: SE-MF-000004861. 

Manufacturer certified according to:
ISO 90001 nr CH 15/1319
ISO 14000 nr CH 15/1320
REACH 
IMDS

Registered at: 
MDR EUDAMED by the European Commission to implement Regulation (EU)
2017/745 on medical devices.

UDI DI for the the Careva system 7350037450018U for the Crossit system 7350037450028 W

The CE marking shows that the manufacturer has determined that the product meets EU standards for safety, health and environmental protection. The marking is required for products from all over the world to be sold in the EU.