EDEN FEMININE CARE LLC

Eden Feminine Care LLC specializes in feminine hygiene and menstrual management products. Their portfolio includes unscented menstrual tampons, unscented menstrual pads, and menstrual underwear. These devices are designed to address menstrual needs without artificial scents, focusing on comfort and hygiene.

Eden Feminine Care LLC is based in the United States. Since the company operates within the U.S., its devices are subject to FDA regulations. The FDA UDI database lists their products, ensuring traceability and compliance with U.S. medical device requirements. This oversight helps maintain consistency in safety, performance, and quality standards.

Eden Feminine Care LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is used to track and identify medical devices in the U.S., ensuring transparency in their distribution and compliance with regulatory requirements. Listing in this database helps healthcare providers and regulators verify product details.

Eden Feminine Care LLC’s devices fall into two FDA classification categories: Class I and Class II. Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a moderate risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s purpose, potential risks, and intended use.