OWEN MUMFORD LIMITED

Owen Mumford Limited produces a range of single-use medical devices, including manual blood lancing devices like safety lancets for both professional and patient use. Their portfolio also includes mechanical syringe-loaded injectors for medications and vaccines, vaginal dilators for medical training and assessment, mechanical pressure algometers for pain sensitivity evaluation, and empty mechanical self-injectors designed for pre-filled medication systems. These devices are primarily manual and intended for clinical or home use.

Owen Mumford Limited is headquartered in the United States. The company’s location is relevant for understanding its regulatory jurisdiction and compliance framework, particularly for devices authorised under FDA guidelines.

Owen Mumford Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, regulators, and other stakeholders by linking each device to its specific details, such as model, manufacturer, and classification.

Owen Mumford Limited’s devices fall under Class I and Class II classifications under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each device.

Owen Mumford Limited’s blood lancing devices, such as their Unistik series, are designed as single-use manual lancets, often incorporating safety features like needle guards to minimise post-procedure risks. These devices are engineered for precision and ease of use, catering to both professional healthcare settings and patient self-management. Their classification as Class I or II ensures compliance with FDA standards for safety and performance, depending on the specific model.