Guangzhou Yongyi Industrial Co., Ltd.

Guangzhou Yongyi Industrial Co., Ltd. specializes in electric breast pumps. These devices are designed to assist lactating individuals in expressing breast milk, often featuring digital controls, variable suction settings, and models like the Momspeace series, Kidro Digital Electric Breast Pump, and Dr. Brown’s Digital Electric Breast Pump. The company’s focus is on lactation support technology, ensuring functionality and user convenience.

The company is based in the United States, which means its devices must comply with U.S. medical device regulations. Since these products fall under the FDA’s jurisdiction, they are subject to classification, registration, and reporting requirements specific to the U.S. market, such as listing in the FDA’s 510(k) and UDI systems. Compliance ensures the devices meet safety, performance, and labeling standards before reaching consumers.

The company’s devices are listed in the FDA’s 510(k) and UDI registries. The 510(k) process demonstrates that the devices are substantially equivalent to legally marketed predicates, while the UDI system ensures unique identification for traceability, safety monitoring, and regulatory tracking. These listings help authorities and healthcare providers verify compliance and recall information efficiently.

The company’s electric breast pumps are classified as Class II devices. This classification typically applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices require pre-market notification (such as a 510(k)) to confirm compliance with regulatory requirements before commercial distribution.