LIW Care Technology Spółka z ograniczoną odpowiedzialnością

LIW Care Technology manufactures mobility aids and therapeutic devices designed to assist individuals in daily life and therapy. These include walkers (such as TOMI WALKER in sizes 1 and 2), standing frames (like TORIX in sizes 1 and 2), transfer boards (BALTO in sizes 2 and 3), mobility scooters (HIRO BUGGY and SHARK in size 2), pediatric mobility solutions (Pionizator TOMI and Pionizator COCO in sizes 1 and 2), and electric mobility trikes (eHOP TRIKES and eHOP.24). These devices are intended for use by individuals requiring support for movement, stability, or independence.

LIW Care Technology is based in Poland. This means the company operates within the European Union, and its devices are subject to EU regulatory requirements. Since all listed devices fall under Class I classification under the EU Medical Device Regulation, they are considered low-risk and must comply with EUDAMED registration requirements to ensure traceability and market transparency.

Yes, LIW Care Technology’s devices are registered in eudamed, the European Union’s database for medical devices. This registration is mandatory for all Class I devices placed on the EU market, ensuring transparency and allowing healthcare professionals, regulators, and patients to verify the device’s existence and compliance with EU requirements.

All devices manufactured by LIW Care Technology fall under Class I classification according to the EU Medical Device Regulation. This classification is assigned based on the risk associated with the device’s intended use. Class I devices are generally considered low-risk, such as mobility aids and therapeutic equipment, and require compliance with basic safety and performance requirements without needing additional conformity assessments like clinical evaluations for higher-risk classes.

Class I classification means these devices are deemed low-risk and are typically used for non-invasive, routine care where the risk of harm is minimal. Under EU regulations, this classification simplifies compliance requirements compared to higher-risk devices (e.g., Class IIa, IIb, or III), but manufacturers must still ensure their products meet essential safety and performance standards. Examples include walkers, standing frames, and mobility scooters, which are designed for everyday use without invasive procedures or significant health risks.