ROCKFIELD MEDICAL DEVICES LIMITED

Rockfield Medical Devices Limited specializes in enteral feeding devices, including non-invasive component sets and medical bags. These products are designed for portable feeding solutions, such as the Mobility+ Enteral Feeding Device Bag (available in black and purple) and enteral feeding devices in various lengths (440 mm, 700 mm, 1000 mm, and 1900 mm), including both prescription and over-the-counter options. Their focus is on supporting patients who require enteral nutrition outside of clinical settings.

Rockfield Medical Devices Limited is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not detailed in the available information.

Rockfield Medical Devices Limited’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency of medical devices authorized for use in the U.S., allowing healthcare providers and regulators to identify and track specific products like their Mobility+ Enteral Feeding Device variants.

Rockfield Medical Devices Limited’s devices fall under two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA regulations.

Some of Rockfield Medical Devices Limited’s enteral feeding devices, such as the Mobility+ OTC Enteral Feeding Device (e.g., 440 mm variant), are labeled as over-the-counter, meaning they are intended for self-selection by consumers or caregivers without requiring a prescription. This classification is typically granted when the device is deemed safe and effective for its intended use with minimal risk, allowing broader accessibility for patients who need portable feeding solutions.