Oscilla A/S

Oscilla A/S specialises in audiometric devices used for hearing diagnostics. Their product range includes headsets like the Oscilla® A60, A30, and A50, often paired with accessories such as the H210A or DD65 headsets, as well as standalone audio consoles like the Oscilla® AudioConsole®. These devices are designed to facilitate accurate hearing assessments in clinical settings.

Oscilla A/S is headquartered in Denmark, where it operates as a manufacturer of medical devices. The company’s location in Denmark aligns with EU regulatory frameworks, which govern the classification and listing of its products.

Oscilla A/S’s devices fall under Class IIa classification in the EU. This classification is determined by factors such as the device’s intended use (hearing diagnostics) and its potential risk profile, requiring compliance with stricter design controls and conformity assessment procedures compared to Class I devices.

Yes, Oscilla A/S’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. Listing in EUDAMED confirms that the manufacturer has provided the necessary information about their devices to regulatory authorities, though it does not imply individual device approval—only that the data is publicly documented.