Aurum Group Ltd

Aurum Group Ltd specializes in mandible-repositioning sleep-disordered breathing orthoses. These devices, such as the Vivos DNA, Vivos mRNA, and Vivos mmRNA, are designed to reposition the jaw during sleep to improve airway patency. This helps manage conditions like obstructive sleep apnea by reducing interruptions in breathing.

Aurum Group Ltd 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 provided information.

Aurum Group Ltd’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices that have been authorized for use in the United States, ensuring traceability and compliance with regulatory requirements.

Aurum Group Ltd’s devices fall under FDA Class II classification. This classification is assigned based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.