GVB-geliMED GmbH

GVB-geliMED GmbH specializes in producing accessories for electrophysiological diagnostics, particularly for neurodiagnostic procedures. Their product range includes EEG hoods (such as the Schröter model), electrode boards, electrode adapters, electrode braids, and electrode holders. These devices are designed to support clinical and practice-based applications like EEG and EMG recordings, ensuring compatibility with existing diagnostic equipment.

GVB-geliMED GmbH is based in Germany, which means its devices are subject to European Union (EU) regulatory requirements. Since the company’s products fall under Class I medical devices, they must comply with EU regulations, including registration in the EUDAMED database—a central EU database for medical devices—to ensure traceability and transparency.

GVB-geliMED GmbH’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registration is important because it ensures that the devices meet EU regulatory standards, allows healthcare professionals to verify their legitimacy, and supports compliance with EU medical device legislation, including traceability and market surveillance requirements.

GVB-geliMED GmbH’s devices are classified as Class I medical devices under EU regulations. This classification applies to low-risk products, such as accessories for neurodiagnostics like EEG hoods and electrode components. Class I devices typically require basic conformity assessment procedures, such as manufacturer self-certification, to demonstrate compliance with essential safety and performance requirements before being placed on the market.