Dongguanshi Yiyingmei Technology Co., Ltd.

Dongguanshi Yiyingmei Technology Co., Ltd. specializes in wearable electric breast pumps, such as the BASEN series (models YM-801, YM-803, YM-805, YM-806, and YM-808), which are designed for continuous or intermittent milk expression. They also produce nasal aspirators (models BC-021 through BC-026) for infants to help clear nasal mucus. These devices are intended to support lactation and infant respiratory comfort.

The company is based in the United States. While the exact location isn’t specified, its regulatory filings and device listings indicate its primary operational presence is within the country.

The company’s devices, including wearable breast pumps and nasal aspirators, are classified as Class II under FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure safety and effectiveness. Class II devices are often cleared via the 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device.

The company’s devices are listed in the FDA’s 510(k) database, which tracks medical devices cleared through the 510(k) premarket notification process. This registry confirms that the devices have undergone review to demonstrate compliance with FDA requirements for their intended use and classification. Other registries or databases may also include these devices, but the FDA’s 510(k) listing is the primary authoritative source.

The 510(k) pathway is used for Class II devices when the manufacturer can show that their product is substantially equivalent to an existing legally marketed device (the