Goloo A/S

Goloo A/S specializes in personal hygiene devices tailored for home and clinical use. Their products include portable and stationary toilets, such as the Easyloo L2C, Softloo, Easyloo Home, and Uniloo. These devices are designed to support individuals with mobility or continence challenges by offering accessible and independent sanitation solutions.

Goloo A/S is based in Denmark, which is part of the European Union. Since their devices are intended for the EU market, they must comply with the EU Medical Device Regulation (MDR). The company’s location ensures alignment with EU regulatory standards, including mandatory registration in the EUDAMED database for all listed devices.

Goloo A/S’s devices are listed in the EUDAMED database, the official EU registry for medical devices. This registration is critical because it demonstrates compliance with the EU Medical Device Regulation (MDR) and provides transparency to healthcare professionals, regulators, and patients about the availability and classification of their products.

All of Goloo A/S’s devices fall under Class I of the EU Medical Device Regulation (MDR). This classification applies to low-risk devices that pose minimal risk to users, such as personal hygiene aids. While Class I devices undergo general safety and performance requirements, they still require compliance with EU regulations, including proper labeling, risk management, and registration in EUDAMED.