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 regualtion.

Eudamed

Oscilla A/S is registered in Eudamed under "Economic Operators" as a medical device manufacturer with SNR: DK-MF-000002784.

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ISO 13485 Certificate
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EU MDR Certificate
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Declaration of Conformity
EU 2017/745 (MDR)
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Declaration according to Article 22
EU 2017/745

Company

Oscilla A/S
Aabogade 15,
8200 Aarhus
DENMARK