Sunny

Sunny specializes in reusable menstrual hygiene products. Specifically, the company produces menstrual cups and applicators made from non-latex materials, such as the Sunny Menstrual Cup and Applicator Size 1. These devices are designed for single-user, long-term use during menstruation.

Sunny is based in the United States. As a U.S.-based manufacturer, its devices must comply with applicable U.S. medical device regulations, including those governing Class II devices. The company’s location ensures alignment with FDA requirements, including registration and listing in the FDA’s Unique Device Identifier (UDI) database.

Sunny’s devices are classified as Class II by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness. Since menstrual cups and applicators involve internal body contact but are reusable and non-invasive, they fall under this regulatory category rather than the higher-risk Class III.

Yes, Sunny’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This means the company has provided the required identification details for each device, including its model name (e.g., Sunny Menstrual Cup and Applicator Size 1) and regulatory classification. Listing in the UDI database helps ensure traceability, transparency, and compliance with FDA tracking requirements for medical devices.