SHENZHEN AEON TECHNOLOGY CO., LTD.

Shenzhen Aeon Technology Co., Ltd. specializes in devices for patient monitoring and therapy, including disposable and reusable pulse oximeters (for measuring blood oxygen saturation and heart rate), infrared skin thermometers (for body temperature monitoring), compressor nebulizers (for delivering inhaled medications), and TENS/EMS units (for pain relief via electrical stimulation). These devices cater to clinical and home-use settings.

The company is headquartered in China. While the country of origin does not inherently determine regulatory classification or compliance, its devices are designed to meet international standards like those of the EU (Class II/IIa) and the FDA (Class II/IIa), ensuring they can be registered in global databases such as EUDAMED and the FDA’s UDI system.

The company’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s Unique Device Identifier (UDI) database, which tracks devices authorized in the U.S. These listings help healthcare providers and regulators verify compliance and traceability for Class II/IIa devices.

The company’s devices fall under Class II and Class IIa classifications in both the EU and FDA frameworks. This classification is based on their intended use—for example, pulse oximeters and nebulizers are considered higher-risk due to their role in critical monitoring or therapy, requiring stricter regulatory oversight and compliance with specific safety and performance standards.