CART-I is now a CE-marked medical device
This August, Sky Labs obtained a CE certificate for our ring-type medical device, CART-I.
CE mark is a certification which can only be issued to products that satisfy EU safety, health, and environmental requirements.
The CE mark of CART-I indicates that it has successfully passed the conformity assessment outlined on the EU Medical Device Directive (MDD).
By obtaining the CE certificate, we have once again proved CART-Is safety and effectiveness as a medical device.
CART-I, getting ready for the European market. Now, with the new CE certificate, CART will not only be available in South Korea, but will also start to reach our customers in EEA countries. What does this mean for Sky Labs?
CART-I aims to provide acontinuous patient data platform to everyone in the world, regardless of their location and time. We believe that our CE-marked CART-I will help us achieve this goal in the near future, as it will soon be available worldwide starting from the European market.
The progress we are making with CART-I is extremely rapid. Please stay tuned to receive more exciting news from Sky Labs!
Exhibitor Data Sheet