Tiger Medical Group

Tiger Medical Group specializes in single-use and reusable medical devices primarily for surgical and patient care applications. Their product portfolio includes surgical/medical face masks, airway suction catheters, surgical towels, vaginal speculums, and intermittent electronic patient thermometers. These devices are designed to support procedural needs and clinical monitoring in healthcare environments.

Tiger Medical Group is headquartered in the United States. Since their devices fall under FDA jurisdiction, they operate under U.S. medical device regulations, including compliance with the requirements for Class II devices. This classification applies to their products due to their moderate risk level, requiring specific controls to ensure safety and effectiveness.

Yes, Tiger Medical Group’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry is mandatory for Class II devices in the U.S. to ensure traceability, transparency, and compliance with post-market surveillance requirements. The UDI system helps track devices throughout their lifecycle, from manufacturing to patient use.

Tiger Medical Group’s devices are classified as FDA Class II medical devices. This classification is assigned based on the risk level of the products—Class II devices pose moderate risks and require special controls beyond general controls to mitigate those risks. Examples include their single-use masks, suction catheters, and thermometers, which require validation of performance and safety without reaching the higher scrutiny of Class III devices.