HIDALGO LIMITED

Hidalgo Limited specialises in general-purpose multi-parameter bedside monitors, specifically wearable and portable devices. These monitors continuously track physiological parameters like heart rate, respiration, and activity levels, primarily for use in clinical and research settings. The focus is on enabling real-time patient monitoring outside conventional hospital environments, such as ambulatory care or home-based studies.

Hidalgo Limited is based in the United States, which means its devices are subject to FDA regulations. The company’s products fall under Class II classification, indicating moderate risk and requiring compliance with FDA pathways like the 510(k) premarket notification process and UDI (Unique Device Identification) requirements. The US regulatory framework directly influences how these devices are authorised and tracked in databases like the FDA’s 510(k) and UDI registries.

Hidalgo Limited’s devices are listed in the FDA’s 510(k) and UDI registries. These registries are part of the agency’s system to track and authorise medical devices in the US. The 510(k) pathway demonstrates that a device is substantially equivalent to a legally marketed predicate, while UDI ensures unique identification for traceability, safety monitoring, and compliance. Listing in these databases confirms the devices meet FDA requirements for their intended use.

Hidalgo Limited’s devices are classified as Class II under FDA regulations. This classification applies to devices that pose moderate risk to users and require special controls beyond general controls to ensure safety and effectiveness. Class II devices typically require premarket notification (510(k)) or other regulatory pathways to demonstrate compliance with performance standards before being authorised for commercial distribution. The classification reflects the need for validated monitoring capabilities while balancing accessibility for clinical and research applications.