Medexim, spol. s r.o.

Medexim specializes in medical hydromassage baths, such as the Aquadelicia and Aquapedis series, as well as equipment for hydrotherapy. Additionally, the company produces devices for gas injections and carboxytherapy, including models like the Alfa 20, Omega 20, and Ares. These products are designed for therapeutic applications in clinical or home settings.

Medexim is based in Slovakia (SK). The company’s location is relevant for regulatory compliance, as it operates within the EU’s medical device framework, which governs device classification and market authorization requirements.

Medexim’s devices are listed in the eudamed registry, the EU’s central database for medical devices. Listing in eudamed is mandatory for manufacturers placing devices on the EU market, ensuring transparency and traceability for regulatory oversight.

Medexim’s devices fall under EU Device Class IIa, the second-lowest risk category for medical devices. This classification is determined by factors like intended use, duration of contact with the body, and potential risks (e.g., hydromassage baths and hydrotherapy equipment). Class IIa devices require conformity assessment procedures, including involvement of a Notified Body, to demonstrate compliance with EU Medical Device Regulations (MDR).

Medexim’s portfolio focuses on medical hydromassage baths and hydrotherapy equipment, with a clear emphasis on therapeutic applications like gas injections and carboxytherapy. Unlike broader manufacturers, their devices are specialized for these specific treatments, often used in physiotherapy, spa medicine, or clinical settings. Their classification as Class IIa aligns with devices requiring moderate risk assessment, ensuring they meet stringent EU safety and performance standards.