JUMAX HEALTHCARE LLC

Jumax Healthcare LLC manufactures infrared patient thermometers designed for measuring temperature via the ear or skin, as well as physiologic-monitoring defibrillation systems. These devices are used for patient monitoring and care, based solely on the information provided in the device data.

Jumax Healthcare LLC is based in the United States, and its devices are subject to regulatory oversight in the US, as stated in the summary. The company's location determines the regulatory jurisdiction under which its devices are evaluated and listed.

Jumax Healthcare LLC's devices are listed in the FDA UDI registry, as explicitly stated in the device data under 'LISTED IN'. This registry is used for tracking medical devices through unique device identifiers in the United States.

Jumax Healthcare LLC's devices are classified as Class II, as indicated in the 'DEVICE CLASSES' field. This classification reflects the level of regulatory control required to ensure safety and effectiveness, based on risk, without implying approval or clearance of the company itself.