United Care Products B.V.

United Care Products B.V. specializes in two primary categories of medical devices: hydrotherapy baths/tanks and mobile bathing/changing tables. Their product line includes models like the Sherpa 3 series (with variations such as electric spreader bars, drive mechanisms, and X-shaped spreader bars), WendyDrive 2, Sherpa 2 (with 4F and 6F electric spreader bar options), and the Zido. These devices are designed to assist individuals with reduced mobility in bathing and changing safely.

United Care Products B.V. is headquartered in the Netherlands. The company operates within the EU regulatory framework, which influences its product development, compliance, and registration processes.

Yes, United Care Products B.V.’s devices are registered in the EUDAMED database, which is the European Union’s medical device registry. This database is used to track and monitor medical devices that have been authorized for placement on the EU market, ensuring transparency and traceability for regulatory oversight.

United Care Products B.V.’s devices are classified as EU Class I medical devices. This classification is determined based on factors like the intended use, risk level, and potential impact on patient safety. Class I devices are generally considered low-risk but still require compliance with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) to ensure safety and performance.