Shenzhen Kairuigeli Investment Consultant Co., Ltd.

The company produces reusable general-purpose patient temperature probes, infrared ear thermometers, and fetal Doppler system probes. These devices are designed for monitoring patient temperature and non-invasive prenatal fetal heart rate detection, respectively. The focus is on reusable and disposable-free solutions for clinical use.

The company operates from the United States. While its name suggests a Shenzhen origin, its manufacturing and business activities are conducted within the US market, aligning with regulatory and operational needs there.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II medical devices, which include temperature probes and fetal Doppler systems, by assigning a unique identifier to each device type.

All devices produced by the company fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure safety and effectiveness. Examples include reusable temperature probes and fetal Doppler probes.