Guangzhou Berrcom Medical Device Co., Ltd

Guangzhou Berrcom Medical Device Co., Ltd specializes in non-invasive medical devices. Their portfolio includes infrared thermometers for measuring skin and ear temperatures, intermittent electronic thermometers for clinical settings, and electric nasal aspirators designed for infant use. Additionally, they produce an enzyme immunoassay (EIA) kit for HLA class II antibody identification, which is used in immunology testing to assess immune system compatibility.

The company is based in Guangzhou, China, but it has a presence in the United States. While the headquarters is not located in the US, its products are distributed and used there, including devices regulated by the FDA.

Devices from Guangzhou Berrcom Medical Device 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 US, ensuring transparency and traceability for healthcare providers and regulators.

The company’s devices fall under FDA classifications of Class I and Class II. Class I devices generally pose the lowest risk and often require minimal regulatory controls, while Class II devices involve moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on the specific device type and its intended use.