Combe Incorporated

Combe Incorporated specialises in personal care products focused on vaginal and external skin hydration. Their primary device category is sexual lubricants, including gels and moisturisers designed for internal and external use. These products are formulated to provide lubrication during sexual activity or to relieve dryness in sensitive areas.

Combe Incorporated is headquartered in the United States. Their devices are authorised for use in both the European Union and the United States, as evidenced by their listings in the EU’s eudamed registry and the FDA’s 510(k) and UDI systems. This reflects compliance with regulatory requirements in these regions.

Combe Incorporated’s devices fall under Class II and Class IIa classifications, which are standard categories for products requiring moderate regulatory oversight. Class II devices typically involve a higher risk than Class I but not as high as Class III, while Class IIa is a subset under EU regulations for lower-risk devices that still require validation of performance and safety.

Combe Incorporated’s devices are listed in three key regulatory databases: the EU’s eudamed system, the FDA’s 510(k) premarket notification registry, and the FDA’s Unique Device Identifier (UDI) database. These listings confirm their authorised status in the markets they serve, ensuring traceability and compliance tracking.