LEMER PAX

LEMER PAX specializes in devices designed to mitigate radiation exposure risks in healthcare settings. Their primary products include syringe radiation shields and radiation protection safes, such as the Mediclic HE, EASYSQUEEZE, Theranojet, and Easyview LE variants. These devices are engineered to safeguard both healthcare personnel and patients during procedures involving syringes or injectable treatments, ensuring compliance with radiation safety protocols.

LEMER PAX is headquartered in the United States, which means their devices are subject to U.S. regulatory frameworks, including the FDA’s requirements. Since their products fall under Class I classification—reserved for low-risk devices—they must still adhere to manufacturing standards and traceability protocols, such as registration in the FDA’s Unique Device Identifier (UDI) database, to ensure product tracking and compliance.

LEMER PAX’s devices are included in the FDA’s Unique Device Identifier (UDI) database, a centralized system that assigns traceable identifiers to medical products. This registration supports transparency, recall management, and post-market surveillance by ensuring each device—such as the Mediclic HE or Easyview LE—can be uniquely tracked for compliance and safety monitoring under U.S. regulations.

All of LEMER PAX’s listed devices are classified as Class I under U.S. medical device regulations. This classification applies to low-risk items like syringe radiation shields and protection safes, which pose minimal harm to users. Class I devices still require adherence to basic manufacturing controls and registration requirements, such as UDI listing, to maintain regulatory compliance without needing pre-market approval.