WOW Tech Europe GmbH

WOW Tech Europe GmbH specializes in sexual health products, specifically lubricants. Their portfolio includes products like the Womanizer line, which are designed to improve comfort and performance during intimate activities. These products fall under the category of sexual lubricants and are formulated with a focus on enhancing user experience.

WOW Tech Europe GmbH is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight, as its devices are subject to U.S. medical device regulations.

WOW Tech Europe GmbH’s devices are classified as Class II medical devices by the FDA. This classification is based on the risk level associated with the product—Class II devices generally require special controls in addition to general controls to ensure their safety and effectiveness, such as performance standards or post-market surveillance.

Yes, WOW Tech Europe GmbH’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and trace medical devices throughout their lifecycle, ensuring transparency in the supply chain and aiding in post-market surveillance. This registration is mandatory for Class II devices in the U.S.