Regulus Global LLC

Regulus Global LLC specializes in single-use medical devices for emergency and first aid scenarios. Their primary products include cricothyrotomy kits, which are used for establishing an emergency airway when other methods fail, and non-medicated first aid kits designed for immediate wound care. These devices are intended for pre-hospital and clinical environments where quick access to supplies is essential.

Regulus Global LLC is based in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps ensure compliance with U.S. regulatory requirements and supports traceability for these Class I devices.

Regulus Global LLC’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing is important because it provides transparency and traceability for Class I devices, which are generally considered low-risk but still require identification to meet regulatory standards.

Regulus Global LLC’s devices fall under Class I classification, which is the lowest risk category for medical devices. Class I devices typically pose minimal risk to users and are subject to the least regulatory oversight, though they still must comply with general controls like good manufacturing practices and labeling requirements.