Quality & Regulation
Oscilla A/S is a Danish ISO 13485 certified medical device company. Manufacturing and development are based on over 60 years of experience in screening and diagnostics solutions for hearing professionals.
MDR Regulation
The new MDR regulation, EU 2017/745, went into effect on May 26, 2021 and strengthened requirements for patient and data security for medical devices and software. The new Oscilla® audiometers and the AudioConsole® software have been approved under the new MDR regulation.
Eudamed
Oscilla A/S is registered in Eudamed under "Economic Operators" as a medical device manufacturer with SNR: DK-MF-000002784.
FDA Medical Device registration
The Oscilla products are FDA listed.
FDA Registration Number: 3027357482
FDA Owner Operator Number: 10088355
FDA Registration Number: 3027357482
FDA Owner Operator Number: 10088355
ISO 13485 Certificate
EU MDR Certificate
Declaration of Conformity
EU 2017/745 (MDR)
EU 2017/745 (MDR)
Declaration according to Article 22
EU 2017/745
EU 2017/745
