Since 1984 a tradition of quality
BIONEN is an Italian family company with a strong connection to its territory. The product portfolio is completely designed and produced in Italy.
Who we are
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.
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.
Download our certifications
Our story
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.
1989
In 1989 BIONEN was born, specialized in design, production and marketing of medical devices for neurophysiopathology.
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.
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.
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.
2010
BIONEN obtains the FDA Clearance for its main products, the Needle Electrodes for EMG and EEG
2019
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.
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Vision
We are committed to supporting Key Opinion Leaders in innovation in the neurodiagnostics sector, providing advanced and reliable solutions that improve the quality of life of patients and support the advancement of neuroscientific research.
Mission
Our mission is to design, produce and supply the highest quality neurodiagnostic electrodes and accessories, aimed at meeting the needs of healthcare professionals and researchers in the field of neurology. Through continuous innovation, manufacturing excellence and impeccable customer service, we are committed to ensuring precise diagnostic results and effective therapies to improve the well-being of patients suffering from neurological disorders.