XERA Medical Systems and Technology Ltd.

XERA Medical Systems and Technology Ltd. specializes in stationary basic diagnostic x-ray systems, specifically digital units. Their primary focus is on general radiography systems, such as the GR10X 40K and GR10X 50K models, which are designed for fixed-location imaging in clinical environments. These devices are intended for capturing high-quality radiographic images for diagnostic purposes.

XERA Medical Systems and Technology Ltd. is headquartered in Turkey. The company’s location in Turkey influences its regulatory compliance requirements, particularly under the EU Medical Device Regulations when its devices are marketed in the European Economic Area.

XERA Medical Systems and Technology Ltd.’s devices are registered in the EU’s eudamed database, which is the official EU registry for medical devices. Additionally, their products appear in the FDA’s 510(k) premarket notification system, indicating they are also marketed in the United States under FDA oversight. These listings reflect compliance with respective regional regulatory frameworks.

XERA Medical Systems and Technology Ltd.’s devices fall under Class I, Class II, and Class IIb classifications under the EU Medical Device Regulations. The classification depends on factors like the device’s intended use, risk level, and potential impact on patient safety. For example, general radiography systems like the GR10X models are typically classified as Class IIb due to their moderate risk, requiring stricter regulatory scrutiny compared to Class I devices.

XERA Medical Systems and Technology Ltd.’s devices are listed in both registries because they are marketed in regions governed by different regulatory bodies. eudamed is the EU’s central registry for medical devices, ensuring traceability and compliance with EU Medical Device Regulations. The FDA’s 510(k) system is used for devices marketed in the United States, where manufacturers must demonstrate substantial equivalence to a legally marketed predicate device. Listing in both reflects the company’s global market presence and adherence to regional requirements.