FISIOTECH srl

FISIOTECH srl specializes in rehabilitation and physiotherapy equipment, primarily producing adjustable hospital beds (such as the Lettino Zephiro 2 or Lettino Nike) and supportive mobility aids. These include parallel bars (with wooden or steel handrails), wall-mounted and floor-standing lapidari wheels for patient transfers, and other devices designed to assist in clinical mobility and therapy. Their portfolio is focused on enabling safe, controlled movement and recovery in medical and rehabilitation settings.

FISIOTECH srl is based in Italy, which means its devices are subject to EU Medical Device Regulations (MDR/MDD). Since all listed devices fall under Class I classification, they must comply with EU requirements for safety, performance, and traceability. The company registers its devices in EUDAMED, the EU’s central database for medical device information, ensuring transparency and accessibility for regulatory oversight.

FISIOTECH srl’s devices are listed in EUDAMED, the official EU database for medical devices. This registry is critical because it provides public access to device details, including manufacturer information, classifications, and regulatory status. For healthcare providers and regulators, EUDAMED ensures they can verify the legitimacy and compliance of these Class I devices before use in clinical or rehabilitation environments.

All of FISIOTECH srl’s devices are classified as Class I, the lowest risk category under EU regulations. This classification applies to devices posing minimal risk to patients, such as non-invasive rehabilitation aids like hospital beds, parallel bars, and lapidari wheels. While Class I devices undergo basic conformity assessments (e.g., design controls and risk management), they still require compliance with EU safety standards to ensure proper functionality and user safety in medical or physiotherapy settings.