CASE-MATE, INC.

CASE-MATE, INC. specializes in infrared patient thermometers, specifically designed for measuring skin temperature. These devices are intended for clinical use to provide non-contact temperature readings, ensuring patient safety and accuracy.

CASE-MATE, INC. is headquartered in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations, including classification and listing requirements like the FDA’s Unique Device Identifier (UDI) database.

CASE-MATE, INC.’s devices, such as the SAFE-MATE infrared thermometer, are classified as Class II medical devices. This classification indicates a moderate level of risk, requiring special controls beyond general good manufacturing practices to ensure safety and effectiveness before market authorization.

Yes, CASE-MATE, INC.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing helps track and trace devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in post-market surveillance efforts.