PATH medical GmbH

PATH medical GmbH specializes in audiometric devices used for hearing assessment. Their product range includes evoked-potential audiometers, tone audiometers, and impedance audiometers. Examples include bone conduction audiometers like the Bone conductor B71, diagnostic systems such as the Sentiero Advanced, and screening tools like the Sentiero Screening2. They also produce accessories like ear probes, ear tips, and specialized cables.

PATH medical GmbH is based in Germany, as indicated by the country code 'DE'. The company’s headquarters and operations are located within Germany, which aligns with its regulatory submissions and device classifications under EU Medical Device Regulations.

Devices from PATH medical GmbH are listed in the EU’s eudamed registry, which is the official database for medical devices under the EU Medical Device Regulations. Additionally, their devices appear in the FDA’s 510(k) and UDI registries, reflecting their presence in the US market. These listings help ensure compliance and traceability for their products.

PATH medical GmbH’s devices are classified under the EU Medical Device Regulations as Class I, Class II, and Class IIa. The classification depends on factors like the device’s intended use, risk level, and interaction with the patient. For example, simpler accessories like ear tips may fall under Class I, while more complex diagnostic systems like the Sentiero Desktop AuditData Tymp + OAE could be classified as Class II or IIa due to their role in critical assessments.