Guangzhou Red Elephant Medical Technology Co., Ltd

The company specializes in digital expiratory peak flow meters, such as the SpiroLink. These devices are designed to measure and display peak expiratory flow rates, which are used in respiratory assessments to monitor lung function, particularly in conditions like asthma.

The company is based in the United States. While its name suggests a location in Guangzhou, China, its operational headquarters and manufacturing activities are conducted within the US.

The company’s devices, including the SpiroLink, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the United States.

The company’s devices, such as the SpiroLink, fall under Class II classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, beyond general controls.