WHOLE FOODS MARKET CALIFORNIA, INC.

Whole Foods Market California, Inc. specializes in manufacturing unscented menstrual tampons under the 365 brand. These devices are designed for internal menstrual hygiene and are intended for single-use applications, focusing solely on this category of products.

Whole Foods Market California, Inc. is based in the United States. This means its devices are subject to U.S. regulatory requirements, including classification under the FDA’s system and potential listing in domestic registries like the FDA’s Unique Device Identifier (UDI) database.

The menstrual tampons produced by Whole Foods Market California, Inc. fall under the FDA’s Class II regulatory category. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as tampons, which require validation of materials and design.

Yes, the menstrual tampons manufactured by Whole Foods Market California, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning a unique code, ensuring traceability and compliance with U.S. regulatory requirements.