Kateway Limited

Kateway Limited specializes in incontinence sensors and alarm systems. These devices are designed to detect urinary incontinence episodes and provide real-time alerts, helping users manage bladder control issues in home or clinical settings. The focus is on improving monitoring and support for individuals experiencing incontinence.

Kateway Limited is headquartered in the United States. The company’s location is relevant for understanding its regulatory context, as device classification and compliance requirements may vary by region, though the devices themselves are primarily classified under US regulations.

Kateway Limited’s incontinence sensors and alarm systems fall under Class II classification in the US. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance. The classification influences regulatory requirements, including how the devices are reviewed and monitored.

Yes, Kateway Limited’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their lifecycle, ensuring transparency in supply chains and aiding in post-market surveillance. Listing in this registry supports compliance with US regulatory requirements for device identification and traceability.