Changzhou Sifary Medical Technology Co., Ltd.

Changzhou Sifary Medical Technology Co., Ltd. specializes in a range of reusable and dental-specific medical devices. Their portfolio includes surgical tools like reusable surgical binoculars and head-worn surgical lamps, as well as dental equipment such as digital intraoral X-ray systems, intraoral imaging sensors, ultrasonic scalers for dental cleaning, and motorized handpieces for surgical procedures. They also produce endodontic obturation systems and general-purpose surgical microscopes, catering to both surgical and dental clinical needs.

The company is headquartered in the United States. This location ensures compliance with U.S. regulatory requirements for medical devices, including those listed in the FDA’s Unique Device Identifier (UDI) database.

The devices produced by Changzhou Sifary Medical Technology Co., Ltd. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability for healthcare providers and regulators.

The company’s devices fall under two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and often require only general controls, while Class II devices involve a higher level of risk and may require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with.