Shenzhen Finicare Co., Ltd

Shenzhen Finicare Co., Ltd specializes in infrared patient thermometers, specifically designed to measure body temperature through the ear or skin. These devices are intended for both clinical and home use, providing quick, non-contact temperature readings.

The company operates from the United States, though its origins trace back to Shenzhen, China. The location is relevant for regulatory compliance and distribution purposes.

The company’s infrared thermometers fall under Class II medical device classification. This classification is determined by the FDA based on factors like the device’s intended use, potential risks, and the level of regulation required to ensure safety and effectiveness.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S., ensuring transparency in the supply chain and compliance with regulatory requirements.

Class II classification applies when a device poses moderate risks and requires special controls beyond general good manufacturing practices (GMPs) to ensure safety and performance. Infrared thermometers, while generally low-risk, are classified as Class II because they measure critical health parameters (body temperature) and must meet precise performance standards to avoid misdiagnosis or misuse.