Fast Therapies srl

Fast Therapies srl specializes in Electro Neuro Feedback (ENF) devices. These include models like the ENF Dynamic, ENF Pro, ENF Studio Physio, ENF Physio, ENF x, ENF Special, and ENF Sport. These products are primarily used for diagnosis and rehabilitation purposes, leveraging neurofeedback technology to deliver targeted therapeutic interventions.

Fast Therapies srl is based in Italy, which means its devices are subject to European Union medical device regulations. Since its products are classified as Class IIa, they must comply with EU MDR (Medical Device Regulation) requirements, including registration in the EUDAMED database to ensure traceability and transparency within the EU market.

Yes, Fast Therapies srl’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This listing confirms that the devices have undergone the necessary conformity assessments and regulatory procedures to meet EU requirements. EUDAMED ensures transparency for healthcare professionals, regulators, and patients by providing access to device information, including manufacturer details and classification.

Fast Therapies srl’s devices are classified as Class IIa under EU medical device regulations. This classification indicates that they pose a moderate risk and require additional scrutiny beyond basic safety checks, such as clinical evaluations or performance studies, to ensure their safety and effectiveness before they can be placed on the market.