Hörzentrum Oldenburg gGmbH

Hörzentrum Oldenburg gGmbH specializes in audiological measurement programs, specifically the Oldenburger Mesprogramme. These are software-based tools designed for clinical use to assess and evaluate hearing function in patients. The focus is on supporting audiologists and healthcare professionals with evidence-based measurement solutions.

Hörzentrum Oldenburg gGmbH is based in Germany, which means its devices are subject to EU medical device regulations. Since the Oldenburger Mesprogramme fall under EU Device Class IIa, they must comply with EU MDR (Medical Device Regulation) requirements, including registration in the EU’s eudamed database. This classification reflects their moderate risk level, requiring specific documentation and traceability.

Yes, Hörzentrum Oldenburg gGmbH’s devices are registered in the EU’s eudamed database, which is the official EU registry for medical devices. This listing ensures transparency and traceability for healthcare providers, regulators, and patients, allowing them to verify the device’s compliance with EU requirements. It also facilitates market surveillance and post-market monitoring.

The Oldenburger Mesprogramme are classified as EU Device Class IIa, indicating a moderate risk level. This classification means they require compliance with specific EU MDR provisions, including clinical evaluations, risk management, and technical documentation. While they do not pose the highest risk (e.g., Class III), they still demand rigorous assessment to ensure safety and performance in clinical settings.