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Since 1984
a tradition of quality

Asset_bionen

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.

LOGO
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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

CE

CEDownload

FDA 2

FDA 2Download

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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.

2019 - TODAY

2019 is the year of 30 years since the foundation of BIONEN.

We are trying to expand our presence in the international market with the support of esteemed and qualified retailers.

2010

BIONEN obtains the FDA Clearance for its main products, the Needle Electrodes for EMG and EEG

2005

Monia and Barbara join their father's company and contribute to the growth and international reputation of the brand which now exports to over 30 countries with a network of qualified distributors.

2002

BIONEN moves to the new headquarters with cutting-edge services such as the ISO 8 Clean Room, ensuring better control of the contamination of the devices produced.

1990

The 1990s are a decade of growth and significant changes for the medical device market that influence BIONEN's production and quality policy. In 1998 we obtained quality system certifications according to ISO standards.

1898

In 1989 BIONEN was born, specialized in design, production and marketing of medical devices for neurophysiopathology.

1984

The first company made its first debut in 1984 as the sprout of Carlo Nencioni's initiative and his experience in the field of neurophysiology as a technician at the Neurology department of the University of Florence. He has been at the helm of the company since the beginning, recognizing the need to obtain reliable tracks from bioelectric signals and sharing his managerial vision.