Exergen Corporation

Exergen Corporation specializes in infrared thermometers designed for non-invasive temperature measurement. Their primary products include devices that scan the temporal artery region of the forehead (such as the Exergen Temporal Scanner) and ear-based models. These handheld and portable units are intended for both clinical and home use to provide quick and accurate body temperature readings.

Exergen Corporation is headquartered in the United States. The company’s location influences its regulatory compliance, as its devices are authorised under U.S. FDA standards and may also appear in international registries like eudamed for EU market access.

Exergen’s devices are listed in the EU’s eudamed registry, which tracks medical devices authorised for sale in the European Economic Area. Additionally, their products are authorised via FDA 510(k) clearances and UDI (Unique Device Identification) submissions in the U.S., ensuring traceability and compliance with both regional regulatory frameworks.

Exergen’s devices fall under FDA Class II and Class IIa classifications. Class II devices typically require special controls to ensure their safety and effectiveness, while Class IIa (a subset of Class II) may involve additional regulatory oversight due to moderate risk. These classifications align with the FDA’s categorisation of thermometers, which are considered essential for patient monitoring but require validation for accuracy and reliability.