Shanghai Bojin Electric Instrument & Device Co., Ltd.

Shanghai Bojin Electric Instrument & Device Co., Ltd. specializes in manufacturing electric motor-driven power tools for surgical use. Specifically, their devices are designed for bone and joint procedures, such as cutting and drilling during orthopedic surgeries. These tools are intended to provide controlled power for tasks like osteotomies or implant placements, ensuring precision in surgical environments.

The company is based in the United States, though the name suggests its origins may be in Shanghai, China. The location of operations is relevant for regulatory compliance, as their devices are subject to U.S. medical device regulations.

The devices produced by Shanghai Bojin are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S. market, ensuring transparency and traceability for regulatory oversight.

The company’s devices fall under Class I classification in the U.S. This classification is typically assigned to low-risk medical devices, such as surgical power tools for bone and joint procedures. Class I devices are generally subject to fewer regulatory controls but still must comply with federal requirements for safety and performance.