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Since 1984
a tradition of quality

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Who we are

BIONEN is an Italian family company with a strong connection to its territory. The product portfolio is completely designed and produced in Italy.

BIONEN is focused on research, design and production of high quality electrodes and accessories for recording biological signals. Mainly needle and surface electrodes for the detection and measurement of brain (EEG) and muscle (EMG) activity.

With over 30 years of experience, BIONEN has established itself as a reference manufacturer for accessories and consumables for quality diagnostic investigations, with particular attention to the neurophysiological segment.

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Quality system and Certifications

Our Company Quality System complies with the European Standard ISO 13485,2016. which specifies the requirements for the design / development, manufacture, installation and service of medical devices.

All our products comply with Directive 93/42/EEC and its revised versions, for CE marking and a part of these to the FDA Quality Systems Regulation 21 CFR.820.

For an effective guarantee of the control of the level of contamination of the devices, we carry out a part of the production process in a controlled environment (ISO 8 Clean Room) and constantly monitor the level of contamination of both the work environments and the devices in the pre-sterilization phase.

ISO 13485:2016

ISO 13485:2016Download

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We are just enthusiastic

about what we do

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Mission

BIONEN's mission for the future is to be the best choice for its customers, partners and workforce. BIONEN aims to achieve this through the further development of a business model capable of innovation and strong links with the territory in which it operates.