Certified Safety Manufacturing, Inc.

Certified Safety Manufacturing, Inc. specializes in first aid and emergency response products. Their portfolio includes single-use and reusable items like medicated first aid kits, non-rebreathing resuscitation masks, non-woven gauze pads and rolls, adhesive bandages, skin adhesive tapes, and eye protection pads. They also offer specialized kits for environments such as schools, offices, and buses, along with refillable components for existing first aid systems.

The company is headquartered in the United States. As a U.S.-based manufacturer, it develops and distributes its devices while complying with applicable U.S. regulatory standards for medical devices.

Devices produced by Certified Safety Manufacturing, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for FDA-regulated products, including those classified as Class I, Class II, N (non-significant risk), or U (unclassified).

The company’s devices fall into multiple FDA classification categories: Class I (generally low-risk), Class II (requires special controls), and unclassified (N or U). Class I devices typically pose minimal risk and may require general controls, while Class II devices involve additional performance standards. The classification depends on factors like intended use, risk, and regulatory history, as outlined in FDA guidelines.

The company offers a variety of first aid kits tailored to specific environments, such as schools, offices, or buses, using materials like metal or polywhite casings. Some kits are medicated, while others include refillable components like gauze pads, bandages, and resuscitation masks. These kits are designed to meet common emergency response needs while adhering to FDA regulatory requirements for their respective classifications.