Bradacare (XiaMen) Health Technology Co., LTD

Bradacare (XiaMen) Health Technology Co., Ltd. specializes in foldable, non-powered handgrip disability-assistive walkers. Their primary product category includes rollators, which are designed to provide mobility support for individuals who need assistance while walking. These devices are intended to enhance stability and portability for users.

The company is headquartered in China. This geographic location is relevant for understanding regulatory frameworks and manufacturing origins, though it does not directly impact the classification or authorization status of their devices.

Bradacare’s devices are listed in the EU’s EUDAMED registry and the FDA’s UDI (Unique Device Identification) system. These registries help track and identify medical devices for regulatory oversight, ensuring transparency in the supply chain and compliance with global standards.

Bradacare’s devices fall under Class I classification. This classification is typically assigned to low-risk medical devices, such as mobility aids like rollators, which pose minimal risk to users. The classification determines regulatory requirements, with Class I devices generally subject to fewer stringent controls than higher-risk categories.