EBA AG

EBA AG specializes in portable X-ray systems, including the CompactXray and its upgraded model, the CompactXray U. These devices are designed for real-time radiographic imaging in clinical settings, enabling diagnostic visualization without requiring fixed infrastructure.

EBA AG is headquartered in Germany, which places its devices under EU regulatory requirements. Since its products are medical imaging devices, they must comply with EU Medical Device Regulations (MDR) or previous directives, ensuring safety, performance, and traceability in the European market.

EBA AG’s devices are listed in the EU’s eudamed database, the official EU registry for medical devices. This registration is critical because it demonstrates compliance with EU requirements, facilitates traceability for healthcare providers, and ensures transparency in the supply chain for authorities and patients.

EBA AG’s portable X-ray systems fall under EU Device Class IIb classification. This classification is assigned based on risk assessment—Class IIb devices pose moderate to high risks (e.g., ionizing radiation exposure) and require stricter scrutiny, including conformity assessments and technical documentation, to ensure patient safety and device performance.