MDR Regulation
The new European Medical Device Regulation (MDR), EU 2017/745, came into full application on 26 May 2021 and has introduced stricter requirements for patient safety, data security, and clinical documentation for medical devices and software. The latest Oscilla audiometers and the AudioConsole software are fully compliant with the MDR and are certified in accordance with the requirements of EU 2017/745.
Eudamed
Oscilla A/S is registered as a medical device manufacturer in the European EUDAMED database and with the Danish Medicines Agency under SRN (Single Registration Number): DK-MF-000002784.
FDA Medical Device registration
Oscilla's products are registered with the U.S. Food and Drug Administration (FDA).
FDA Registration Number: 3027357482
FDA Owner/Operator Number: 10088355
