ARK INC.

ARK Inc. manufactures the WISKY, a medical device designed for a specific clinical purpose. While the exact function is not detailed, it is classified under EU Device Class IIa, indicating it poses a moderate risk and requires compliance with stringent regulatory controls to ensure safety and performance.

ARK Inc. is based in South Korea. For its devices listed in the EU market, such as the WISKY, the company adheres to relevant regulatory standards to ensure compliance with EU requirements, including those outlined for Class IIa devices.

ARK Inc.’s devices, including the WISKY, are listed in the EU’s eudamed database. This registry is used to track medical devices that have undergone the necessary conformity assessment procedures to be placed on the EU market.

The WISKY, manufactured by ARK Inc., is classified as a Class IIa medical device under EU regulations. This classification is based on its intended purpose and associated risk level, requiring compliance with specific safety and performance standards to ensure proper use and patient safety.