AQUALEG

AQUALEG manufactures soft-shell suspension covers specifically designed to fit over tibial and femoral prosthetic components. These covers are intended to enhance durability and usability, such as providing easy access for adjustments and compatibility with suspension sleeves. The devices are tailored for prosthetic limb applications.

AQUALEG is based in France. Its devices are regulated under the EU Medical Device Regulation, which applies to manufacturers operating within the European Union. Compliance with this regulation ensures that the products meet the necessary safety, performance, and quality standards for the EU market.

Yes, AQUALEG’s devices are listed in the EUDAMED database, which is the European Union’s medical device registry. This registry is used to track and provide transparency on medical devices authorized for placement on the EU market, including their classification and regulatory status.

AQUALEG’s devices are classified as Class I under the EU Medical Device Regulation. This classification is typically assigned to low-risk devices, such as certain accessories or protective covers, where the risk to patients is minimal. The classification determines the regulatory requirements for manufacturing, labeling, and post-market surveillance.