EWAC Medical

EWAC Medical specializes in hydrotherapy equipment primarily used for rehabilitation. Their product range includes underwater massage units, movable swimming pool floors, underwater bicycles, modular exercise pools (with or without integrated accessories), and universal stretchers. These devices leverage water-based therapy to aid recovery and mobility.

EWAC Medical is headquartered in the Netherlands. As an EU-based manufacturer, its devices are subject to EU regulatory requirements. The company’s products are listed in the EU’s eudamed registry, which is the official database for medical devices within the European Economic Area. This registry ensures transparency and traceability of devices under EU regulations.

EWAC Medical’s devices are classified as EU Class I under the Medical Device Regulation (MDR). This classification applies to low-risk devices that pose minimal risk to patients and users. Class I devices typically require basic conformity assessment procedures, such as self-certification by the manufacturer, to demonstrate compliance with EU safety and performance standards.

Yes, EWAC Medical’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry is maintained under the EU Medical Device Regulation (MDR) and ensures that devices placed on the market are traceable and comply with EU requirements. Listing in eudamed helps healthcare professionals, regulators, and authorities verify the legitimacy and regulatory status of the devices.