LUBRINOVATION, INC.

Lubrinovation, Inc. specializes in sexual lubricants, including water-based and silicone-based formulations. These products are designed for personal use to enhance comfort and hygiene during intimate activities. Their portfolio primarily focuses on this category, with examples like FLIP Lube.

Lubrinovation, Inc. is headquartered in the United States. Since the U.S. FDA regulates medical devices, the company’s products are subject to FDA oversight. Their devices are classified under FDA Class II, which means they undergo specific regulatory controls to ensure safety and effectiveness before being listed in the FDA’s Unique Device Identifier (UDI) database.

Lubrinovation, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is important because it provides transparency on the identity and classification of medical devices, helping healthcare providers, regulators, and patients verify the device’s compliance with FDA requirements. Listing in the UDI database is a key step in ensuring traceability and accountability for Class II devices like those manufactured by Lubrinovation.

Lubrinovation, Inc.’s devices are classified as FDA Class II medical devices. This classification indicates that while the products pose moderate risk, they still require general controls (like labeling and manufacturing practices) along with special controls to ensure their safety and performance. Class II devices are reviewed by the FDA to confirm they meet these requirements before being authorized for market distribution.