Bath Concept Cosmetics (Dongguan) Co., Ltd.

Bath Concept Cosmetics (Dongguan) Co., Ltd. specializes in personal lubricants, including water-based and silicone-based formulations. These products are specifically designed for intimate use, such as their example devices Lubefy and SILICONE Personal Lubricant. The focus is on enhancing comfort and safety during personal use.

The company is based in the United States. This location is relevant for regulatory compliance and distribution, particularly when aligning with FDA requirements for medical devices.

The company’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. These registries are critical for tracking and ensuring compliance with U.S. medical device regulations, particularly for Class II devices.

The company’s devices, such as personal lubricants, are classified as Class II medical devices under FDA regulations. This classification is based on their intended use and risk level, requiring premarket notification (510(k)) submissions to demonstrate substantial equivalence to a predicate device.