CLARIPHARM

ClariPharm specializes in reusable menstrual cups and discs made from non-latex materials. These devices are designed for vaginal insertion to collect menstrual flow, providing an alternative to single-use menstrual products. The company’s products are marketed under the SUSTAIN NATURAL brand and are intended for long-term use during menstruation.

ClariPharm is based in the United States. Its devices are specifically intended for use in the U.S., where they must comply with applicable medical device regulations. The company’s products are not marketed or authorized for use outside this jurisdiction.

ClariPharm’s menstrual cups and discs fall under FDA Class II regulatory classification. This classification is assigned based on the risk level of the device, with Class II devices requiring special controls to ensure safety and effectiveness beyond general controls. The classification does not imply regulatory approval but reflects the oversight required for these products.

Yes, ClariPharm’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This database is a public registry that includes information about medical devices authorized for use in the U.S., helping to track and identify them throughout their lifecycle. Listing in the UDI database is a requirement for certain FDA-regulated devices, including those in Class II.