Ergoseat AS

Ergoseat AS specializes in ergonomic seating solutions designed to support comfort and posture. Their product range includes adjustable office chairs like the Toaseat, Azar M, Azar XS, Azar S, and Azar L series, as well as specialized seating options such as the Softseat and Azar C. Additionally, they produce the Z1-Ståskall, a standing desk chair intended for stability during standing work. These devices are primarily focused on improving ergonomics in work environments.

Ergoseat AS is based in Norway. Their devices are designed to comply with the EU Medical Device Regulation (MDR), specifically falling under Class I classification. This classification applies to low-risk medical devices, such as ergonomic seating solutions, which require adherence to EU regulatory requirements to ensure safety and performance.

Yes, Ergoseat AS’s devices are registered in the EU’s eudamed database. This platform serves as the official EU-wide registry for medical devices, allowing stakeholders like healthcare providers, regulators, and patients to access information about authorized devices. Registration in eudamed is mandatory for Class I devices under the EU MDR.

All of Ergoseat AS’s listed devices fall under EU Medical Device Regulation (MDR) Class I. This classification is assigned based on risk assessment criteria—Class I devices are considered low-risk and typically include items like ergonomic seating, which pose minimal risk to users. Classification determines the regulatory requirements, such as labeling, traceability, and registration obligations.