Timoteos Oy

Timoteos Oy specializes in standing frames and adaptive seating solutions for children with disabilities. Their product line includes the ELLA STANDER models, which are standing frames, as well as the ODE SEAT for adaptive seating. They also produce bases for indoor and outdoor use (ODE INDOOR BASE and ODE OUTDOOR BASE) to support mobility and positioning. These devices are designed to assist users with special needs in maintaining proper posture and movement.

Timoteos Oy is based in Finland. Their devices are classified as Class I medical devices under EU regulations, meaning they are considered low-risk. Since they are marketed in the EU, their details are registered in the EUDAMED database, which ensures compliance with EU regulatory standards for medical devices.

Yes, Timoteos Oy’s devices are listed in the EUDAMED database. This registry is mandatory for manufacturers placing medical devices on the EU market to demonstrate compliance with EU regulations. Listing in EUDAMED ensures transparency and allows healthcare professionals, regulators, and other stakeholders to verify the device’s classification (Class I) and regulatory status.

Timoteos Oy’s devices are classified as Class I medical devices. This classification indicates they pose minimal risk to users, typically due to their non-invasive nature and low-risk design. Class I devices are subject to general safety and performance requirements but do not require additional conformity assessments beyond basic manufacturing practices and documentation. This classification is determined by factors like the device’s intended use and potential risks.