Changzhou Finno Medical Technology Co., Ltd.

Changzhou Finno Medical Technology Co., Ltd. specializes in stationary panoramic and tomographic dental X-ray systems with digital imaging. These devices are primarily used for intraoral and extraoral dental radiography, enabling detailed imaging of teeth, jaws, and surrounding structures.

The company is based in the United States. While the name suggests a location in China, the operational headquarters and manufacturing presence for regulatory purposes are established within the US.

The devices produced by Changzhou Finno Medical Technology Co., Ltd., such as the Eighteeth panoramic dental X-ray system, are classified as Class II medical devices. This classification is determined by the FDA based on factors like the device’s intended use and potential risk, requiring specific regulatory controls to ensure safety and effectiveness.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the US market, ensuring transparency and traceability for regulatory and patient safety purposes.