Hill-Rom de México, S. de R.L. de C.V.

Hill-Rom de México, S. de R.L. de C.V. specializes in hospital beds and pressure-relief systems for patient support. Their portfolio includes basic electric hospital beds (like the CareAssist® Bed), alternating-pressure bed mattress overlays (such as the Progressa+ surface), and hospital stretchers—both manual and powered—with surfaces like Stretcher Surface. These devices are designed to aid patient mobility, comfort, and pressure redistribution in clinical environments.

The company is based in the United States, where its devices fall under US regulatory oversight. Their products are classified as either Class I or Class II devices, meaning they are subject to varying levels of regulatory scrutiny depending on their risk profile, with some listed in the FDA’s Unique Device Identifier (UDI) database for traceability and compliance tracking.

Several of the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the US, ensuring transparency and compliance with regulatory requirements. The UDI system is used to standardize device identification across healthcare settings.

The company’s devices are classified as either Class I or Class II under US medical device regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each product.