Anigan Inc.

Anigan Inc. specializes in reusable menstrual cups and discs, which are designed for internal menstrual collection. These products are made from non-latex materials and are intended for single-user, long-term use. The company focuses exclusively on these categories of devices.

Anigan Inc. is headquartered in the United States. The company’s location is relevant for regulatory compliance and customer inquiries, as it operates within the U.S. healthcare and medical device landscape.

Anigan Inc.’s menstrual cups and discs are classified as FDA Class II devices. This classification means they are subject to special controls to ensure their safety and effectiveness, such as performance standards, labeling requirements, or post-market surveillance, but they do not require pre-market approval.

Yes, Anigan Inc.’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S. market, ensuring transparency in supply chains and compliance with regulatory requirements.

Anigan Inc.’s menstrual cups and discs are designed for long-term, single-user reuse, which distinguishes them from disposable alternatives. This design choice aligns with sustainability goals while maintaining hygiene standards through materials like non-latex, which are intended to be durable and safe for repeated use.