Shanghai Neo-Medical Import & Export Co., Ltd.

Shanghai Neo-Medical Import & Export Co., Ltd. specializes in single-use surgical and medical face masks. These include standard designs like earloop masks and tie-on variants, as well as models with integrated shields. The devices are intended for use in healthcare and clinical environments to create a barrier against contaminants during medical procedures.

The company is based in the United States, which means its devices are subject to FDA regulations. Since the products fall under the category of surgical/medical face masks, they are classified as Class II devices under FDA guidelines. This classification requires compliance with specific regulatory pathways, such as the 510(k) premarket notification process and UDI (Unique Device Identification) requirements.

The company’s devices are listed in the FDA’s 510(k) registry, which tracks premarket submissions for Class II medical devices, and the FDA’s UDI (Unique Device Identification) system. These registries ensure transparency and traceability of the devices in compliance with U.S. regulatory requirements.

The face masks manufactured by Shanghai Neo-Medical Import & Export Co., Ltd. are classified as FDA Class II devices. This classification is determined by the agency based on the intended use and risk level of the product. Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, which is reflected in their inclusion in the 510(k) and UDI registries.