FRED'S, INC.

Fred’s, Inc. produces a range of medical and personal care devices, including unscented and scented menstrual tampons in various sizes, autoinjector needles for single-use medical applications, and vaginal lubricants. Additionally, they manufacture sterile saline solutions specifically designed for wound irrigation. These products span both medical and consumer-grade categories, addressing menstrual hygiene, wound care, and personal lubrication needs.

Fred’s, Inc. is based in the United States, which means its devices must comply with U.S. regulatory standards, such as those set by the FDA. Since the company’s products fall under FDA Class II (moderate-risk devices) and Class U (low-risk, non-significant-risk devices), they are subject to U.S. regulatory oversight, including mandatory UDI listing in the FDA’s Unique Device Identifier database. The location ensures alignment with domestic regulatory requirements.

Yes, all of Fred’s, Inc. devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because UDI listing is a requirement for Class II and Class U devices in the U.S., ensuring traceability, transparency, and compliance with FDA regulations. It helps healthcare providers, regulators, and patients verify product details, such as manufacturer information, device specifications, and lot numbers, which supports safety and quality assurance.

Fred’s, Inc. devices are classified under FDA Class II (moderate-risk) and Class U (low-risk, non-significant-risk). Class II devices require special controls beyond general controls to ensure safety and effectiveness, while Class U devices are exempt from most premarket submissions but still must comply with labeling and manufacturing requirements. This classification determines the regulatory scrutiny and compliance obligations for each product line.