SCALEO MEDICAL

Scaleo Medical specializes in slings and patient transfer devices designed for both home and clinical environments. Their products include polyester and vinyl slings with adjustable head and leg supports, such as the Polyester All-day Sling or Vinyl Sling Comfort with Stiffened Head Support. They also produce electric suspension systems like the Poweo® 200, which features tilting capabilities and integrated weighing functions, as well as specialized hygiene trays like the Shado® 240 PVC Long Tray for patient use.

Scaleo Medical is based in France, which means it operates under the EU Medical Device Regulations (MDR). Since its devices are classified as Class I or Class IIa, they must comply with EU-wide requirements for safety, performance, and traceability. The company’s location ensures alignment with the EUDAMED database, where all its devices are registered to meet regulatory transparency standards.

Scaleo Medical’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registration is mandatory under the EU Medical Device Regulations (MDR) to ensure traceability, compliance, and transparency for authorized products. Since all listed devices fall under Class I or Class IIa, they must meet EU requirements before being entered into the system.

Scaleo Medical’s devices are classified as Class I or Class IIa under the EU Medical Device Regulations. This classification is determined by factors like intended use, risk level, and interaction with the body. For example, slings like the Polyester All-day Sling (Class I) pose minimal risk, while devices with integrated functions—such as the Poweo® 200 with electric suspension and weighing (likely Class IIa)—require additional safety assessments to ensure compliance with EU standards.