Shenzhen Pacom Medical Instruments Co., Ltd.

Shenzhen Pacom Medical Instruments Co., Ltd. specializes in infrared thermometers for clinical use. Their devices measure either skin temperature or a combination of ear and skin temperature, designed for non-invasive body temperature assessment in healthcare settings like hospitals and clinics.

The company is based in the United States, though its manufacturing operations are located in Shenzhen, China. The U.S. presence likely supports regulatory compliance and distribution within the American market.

The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries reflect compliance with U.S. medical device regulations, ensuring traceability and regulatory oversight.

All of Shenzhen Pacom Medical Instruments Co., Ltd.’s devices fall under Class II classification. This categorization applies to moderate-risk medical devices that require special controls beyond general controls to ensure safety and effectiveness, such as infrared thermometers used in clinical settings.

The Unique Device Identifier (UDI) system is mandated by the FDA to improve tracking and identification of medical devices throughout their lifecycle. By listing devices in this system, Shenzhen Pacom ensures better inventory management, recall efficiency, and compliance with post-market surveillance requirements for Class II infrared thermometers.