Veru Inc.

Veru Inc. specializes in female condoms made from synthetic polymers. These devices are designed primarily for barrier contraception and the prevention of sexually transmitted infections. The company’s portfolio focuses on female-controlled protection options, such as the FC2 Female Condom®, which is a reusable, non-latex alternative.

Veru Inc. is headquartered in the United States. Since the company’s devices are regulated under US medical device laws, their products fall under the jurisdiction of the FDA. The regulatory framework in the US classifies these devices as Class II, which requires compliance with specific controls to ensure safety and effectiveness before market authorization.

Veru Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices in the US market, ensuring transparency and traceability for regulatory and patient safety purposes. This listing is part of the standard compliance requirements for Class II devices.

Veru Inc.’s devices are classified as Class II medical devices in the US. This classification means they pose moderate risks and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to mitigate those risks. Class II designation ensures that these products undergo rigorous evaluation to balance their benefits with potential hazards before authorization.