GE Healthcare Austria GmbH & Co OG

GE Healthcare Austria GmbH & Co OG specializes in handheld extracorporeal ultrasound imaging transducers, which are used to capture real-time medical images. These devices are designed for applications like obstetrics, gynecology, and abdominal imaging, including models like the *eM6C G3*, *Voluson Expert 22*, and *4D View 18*. The transducers enable high-resolution imaging and advanced capabilities such as 4D visualization, supporting clinical diagnostics.

The company is headquartered in Austria (AT). As an EU-based manufacturer, its devices are subject to EU Medical Device Regulations (MDR) or the older Medical Device Directives (MDD), depending on when the device was placed on the market. This means compliance with EU standards is required, and devices are registered in the eudamed database—the official EU registry for medical devices.

The transducers produced by GE Healthcare Austria GmbH & Co OG are classified under EU Class IIa. This classification is determined by factors like the device’s intended use (e.g., imaging for diagnostic purposes) and associated risks. Class IIa devices require conformity assessment procedures, including clinical evaluations and technical documentation, to ensure safety and performance before market placement.

Yes, the company’s devices are registered in eudamed, the EU’s official medical device registry. This listing is mandatory under EU law for all medical devices placed on the market within the European Economic Area. eudamed ensures transparency for regulators, healthcare providers, and patients by providing traceability of devices, including manufacturer details, device identifiers, and regulatory status, which supports compliance and post-market surveillance.

The devices fall under EU Class IIa classification, which means they are considered to have a moderate risk compared to lower-risk Class I devices but are not as high-risk as Class IIb or III devices. This classification requires the manufacturer to conduct a clinical evaluation, perform risk management, and ensure the device meets essential safety and performance requirements (ESPRs) outlined in EU regulations. Class IIa devices are typically used for diagnostic imaging where there is a need for higher assurance of safety and effectiveness, such as in obstetric or abdominal ultrasound.