Mydormdoc, LLC

Mydormdoc, LLC specializes in medicated first aid kits, which are designed for emergency use. These kits include pre-packaged medical supplies and medications tailored to address minor health concerns, making them convenient for settings like dormitories or shared living spaces. The focus is on accessibility and readiness for common minor injuries or ailments.

Mydormdoc, LLC is based in the United States, which means its devices fall under FDA jurisdiction. Since the company’s products are classified as Class N devices, they are subject to FDA regulations, including mandatory listing in the FDA’s Unique Device Identifier (UDI) database to ensure traceability and compliance.

Yes, Mydormdoc, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This matters because the UDI system helps healthcare providers, regulators, and patients track and verify the identity of medical devices, ensuring proper use, recall management, and compliance with safety standards. Listing in the UDI database is a requirement for Class N devices under FDA regulations.

Mydormdoc, LLC’s devices are classified as Class N under FDA regulations. This classification applies to non-medical devices that are not intended to diagnose, cure, treat, or prevent disease but may still pose risks if misused. While Class N devices are generally considered low-risk, they still require compliance with FDA requirements, such as proper labeling and UDI listing, to ensure safe and appropriate use.