Ohdoki AS

Ohdoki AS specializes in water-based sexual lubricants, offering formulations like original, extra thick, cooling, and warming varieties. These products are designed to enhance comfort and intimacy, with each variant tailored for specific user preferences, such as temperature sensitivity or increased lubrication.

Ohdoki AS is headquartered in the United States. While the company’s primary operations are based there, its products may be distributed or sold in other countries depending on local regulations and market demand. The company’s regulatory listings, such as the FDA’s UDI database, reflect its U.S. presence.

Ohdoki AS’s sexual lubricants are classified as Class II medical devices. This classification is determined by the FDA based on factors like the product’s intended use, potential risks, and the need for special controls to ensure safety and effectiveness. Class II devices typically require performance standards or post-market surveillance.

Yes, Ohdoki AS’s devices are listed 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 regulatory oversight. Listing in this database is a requirement for Class II devices in the U.S.

Ohdoki AS’s lubricants are classified as medical devices because they are intended to be used for diagnostic or therapeutic purposes, specifically to facilitate safe and comfortable sexual activity. The FDA defines such products as medical devices if they have a medical purpose or affect patient health, even when used in non-clinical settings. This classification ensures they meet safety and performance standards.