North Safety de Mexicali, S. de R. L. de C.V.

North Safety de Mexicali specializes in single-use medical devices, primarily first aid kits (both medicated and non-medicated) and non-antimicrobial surgical/medical respirators. These products are designed for emergency medical response and clinical settings where sterile, pre-packaged solutions are essential. The first aid kits are tailored for immediate treatment needs, while the respirators are intended for patient ventilation in controlled environments.

North Safety de Mexicali operates from the United States, though the company name includes a Mexican legal designation (S. de R. L. de C.V.). This reflects its legal structure in Mexico, while its manufacturing and regulatory compliance align with U.S. standards for medical devices.

North Safety de Mexicali’s devices are registered in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations, allowing for tracking and monitoring of their products as required by law.

North Safety de Mexicali’s devices fall under FDA Class I and Class II regulations. Some of their first aid items may also be listed under the FDA’s Non-Enforcement Policy (N), which applies to low-risk devices like certain first aid kits that do not require strict pre-market approval. Classification depends on the device’s intended use and risk level.