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CE Declaration of Conformity

Wheeleo®️ is a CE Class 1 medical device. Download the “declaration of conformity” document below.

What is a Class 1 device?

A Class 1 device is a category of medical devices that are the least intrusive and present the lowest risk to patients, mainly used for simple applications and not requiring external control to ensure their safety.

Class 1 medical devices must comply with specific safety and performance standards set by the relevant regulatory authorities. They may require conformity assessment and must be CE marked to be marketed in the European Union. These rules are designed to ensure that Class 1 devices are safe and effective for their intended use, while minimizing risks to patients and users.

Wheeleo®️ complies strictly with the rules laid down for Class 1 medical devices. It has been designed and manufactured in compliance with the most stringent safety and performance standards, guaranteeing reliability and efficiency for users. By obtaining CE certification, Wheeleo demonstrates its commitment to safety and quality, offering users a reliable, approved mobility solution.

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