Qingdao Likangyuan Medical Device Co., Ltd.

Qingdao Likangyuan Medical Device Co., Ltd. specializes in single-use face masks, including public face masks and disposable surgical masks. These devices are designed for both medical and general use, providing protection against airborne particles and pathogens. The focus is on ensuring barrier protection for users in clinical and non-clinical settings.

The company is based in the United States. This location is relevant for regulatory compliance, manufacturing oversight, and distribution within the US market.

The company’s products, such as public face masks and disposable surgical masks, are classified as Class II (N) devices in the US. This classification is determined by the FDA based on the risk posed by the device, with Class II requiring special controls beyond general controls to ensure safety and effectiveness. The ‘N’ designation indicates they are non-invasive.

The company’s devices are listed under the FDA 510(k) and FDA Unique Device Identifier (UDI) registries. The 510(k) process demonstrates that the device is substantially equivalent to a legally marketed predicate device, while the UDI system ensures traceability and identification of devices throughout their lifecycle. These registries are critical for compliance and market authorization in the US.