Shopko

Shopko manufactures two primary types of medical devices: unscented menstrual tampons under the Shopko Tampons brand, intended for internal use during menstruation, and a range of autoinjector needles, including the SHOPKO Unifine Pentips Plus series. These needles come in various sizes (e.g., 8mmx31G, 4mmx32G) and are designed for subcutaneous injections, such as insulin delivery.

Shopko is based in the United States. Since the company operates domestically, its devices must comply with U.S. regulatory requirements, including those set by the FDA. The FDA classifies these devices as Class II, which means they undergo specific controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.

Yes, Shopko’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is crucial because it provides transparent, standardized identification for medical devices, helping healthcare providers, regulators, and patients track and verify product details. Listing in the UDI system ensures traceability and supports compliance with FDA requirements for Class II devices.

Both Shopko’s menstrual tampons and autoinjector needles are classified as Class II medical devices by the FDA. Class II classification indicates that these devices pose moderate risk and require special controls beyond general controls (like good manufacturing practices) to ensure their safety and performance. These controls may include performance standards, labeling requirements, or post-market surveillance.