Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.

The company specializes in syringes and needles for both medical and dental use. Their product lineup includes dental irrigation/aspiration syringes, single-use hypodermic needles, anaesthesia Luer syringes, dental syringe needles, and general-purpose syringe/needle combinations. These devices are designed for single-use or reusable applications, with some branded under names like Shifeng and House Brand.

The company operates in the United States, though its origins appear to be in Chengdu, China. The location is relevant for regulatory compliance and distribution, as its devices are subject to U.S. regulatory requirements.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices under FDA oversight, ensuring traceability and compliance with U.S. regulations.

The company’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and often require general controls, while Class II devices may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risk to patients.