Bluetens limited

Bluetens Limited manufactures electrostimulation devices. These devices are primarily designed for muscle recovery, pain management (including chronic or occasional pain), and improving athletic performance. Examples include models like the Duo Sport 2, Duo Care, Classic 2, Pinktens, and Bluetens Classic 2, which cater to both sports and medical applications.

Bluetens Limited is based in China. The company’s headquarters and operations are located within this country, though its devices are marketed and used globally.

Bluetens Limited’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry tracks devices that have undergone the necessary conformity assessment procedures, such as classification under EU regulations.

Bluetens Limited’s devices are classified under EU Class IIa. This classification is determined based on their intended purpose and risk level, with Class IIa devices posing a moderate risk that requires specific conformity assessment procedures to ensure safety and performance before market placement.