29V11 Femcare LLC

29V11 Femcare LLC produces unscented menstrual pads and tampons. These devices are designed for single-use personal hygiene during menstruation and are classified under feminine hygiene products. The company focuses exclusively on these two categories, ensuring compliance with basic safety and performance standards for such items.

29V11 Femcare LLC is based in the United States. Since the company operates domestically, its devices are subject to U.S. regulatory requirements, including classification under FDA frameworks. The location ensures adherence to domestic standards for menstrual hygiene products, which may differ from international regulations.

The devices produced by 29V11 Femcare LLC are classified as either Class I or Class II. Class I devices generally pose minimal risk and require less stringent regulatory controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential health impact.

Yes, the devices manufactured by 29V11 Femcare LLC are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices to ensure transparency, traceability, and compliance with regulatory requirements. Listing in the UDI system is a key step for manufacturers to demonstrate accountability and adherence to U.S. medical device regulations.

The classification of menstrual hygiene products as Class II (rather than Class I) depends on factors like the materials used, potential risks such as irritation or allergic reactions, and the need for additional safety measures. Class II devices require special controls beyond general controls to mitigate risks, such as performance standards or post-market surveillance. The FDA evaluates these factors to determine the appropriate classification for each device.