Pjur Group Luxembourg S.A.

Pjur Group Luxembourg S.A. specializes in manufacturing lubricants and intimate hygiene products. Their portfolio includes water-based and silicone-based formulations, such as personal glides, moisturising and sensitive skin lubricants, aloe-based lubricants, and anal glides with added ingredients like provitamin B5. These products are designed for intimate and anal use, catering to specific needs like sensitive skin or enhanced comfort.

Pjur Group Luxembourg S.A. is based in the United States, though the company name includes Luxembourg S.A., which may refer to its legal or corporate structure rather than its primary operational location. The products listed are developed and manufactured under this entity’s oversight.

Pjur Group’s devices are listed under the FDA’s 510(k) pathway, which is a premarket notification process used for Class II medical devices. This pathway demonstrates that the devices are substantially equivalent to legally marketed predicate devices, ensuring compliance with U.S. regulatory standards.

Pjur Group’s lubricants and intimate hygiene products are classified as Class II medical devices. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Pjur Group’s lubricants are differentiated by their formulation variety, including water-based and silicone-based options, as well as specialized variants like aloe-based, provitamin B5-infused, or sensitive-skin formulations. These distinctions cater to specific user needs, such as enhanced hydration, reduced irritation, or targeted anal use, aligning with their classification as medical-grade devices.