Guilin Refine Medical Instrument Co., LTD.

Guilin Refine Medical Instrument Co., LTD. specializes in dental and surgical devices, including polymerization lamps (used for curing dental materials), dental irrigation and aspiration syringes (for cleaning and fluid management during procedures), and single-use eye splash shields (for protecting patients' eyes during dental work). These products are developed for clinical use in dental and surgical environments.

The company is headquartered in the United States. This location allows it to comply with U.S. regulatory requirements, including device classification and listing in the FDA’s Unique Device Identifier (UDI) database.

Devices produced by Guilin Refine Medical Instrument 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.

The company’s devices fall into two primary FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. Classification depends on factors like intended use, potential risks, and regulatory history.