Bionen SAS of Firenze (FI) at MEDICA 2018 in Düsseldorf -- MEDICA - World Forum for Medicine

Bionen SAS

Via Policarpo Petrocchi, 42/1, 50127 Firenze (FI)
Italy
Telephone +39 055 4265945
Fax +39 055 412188
info@bionen.it

Hall map

MEDICA 2018 hall map (Hall 11): stand E12

Fairground map

MEDICA 2018 fairground map: Hall 11

Our range of products

Product categories

  • 01  Electromedical Equipment / Medical Technology
  • 01.01  Diagnostics
  • 01.01.06  Neurological diagnosis, apparatus and instruments

Neurological diagnosis, apparatus and instruments

Our products

Product category: Neurological diagnosis, apparatus and instruments

NCS Subdermal Needle Electrodes

A nerve conduction study (NCS) is a medical diagnostic test commonly used to evaluate the function, especially the ability of electrical conduction, of the motor and sensory nerves of the human body.

BIONEN NCS Subdermal Needle Electrodes are designed and manufactured to guarantee high reliability during the exams.
The needle is made of Stainless Steel AISI 304, this material guarantees strenght and flexibility for a perfect funtionality of the electrode.

For U.S. market: Products with FDA 510(k) clearance

optimized tip grinding process for an easy and painless skin penetration 
same needle holder of EMG concentric needle to avoid changing it during the exam
ergonomic hub for a secure grip by the operator
Packaging: single pouch
Sale Packaging: 25 electrodes
Sterilization: Gamma Rays
Shelf Life: 60 months (5 years) from sterilization

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Product category: Neurological diagnosis, apparatus and instruments

Pressure Biofeedback

Biofeedback is based on the principle that any normally involuntary function of the body, can be controlled at will, if it is monitored and brought to the knowledge of the individual.
The objective of BIONEN Pressure Biofeedback is to make the patient aware, by visual signals, of visceral or motor functions that normally he cannot control at will.
The application of biofeedback in fecal or urinary stress incontinence aims to teach the patient the mechanism of sphincter contraction and improve its strength and durability.

WARNING: Not for U.S. market

Intended Use: Rehabilitation of the pelvic floor muscles. Domestic use.

The device is used for the rehabilitation of the pelvic-perineum muscles to treat pathologies such as dyssynergia and hypotonia/hypertonia of the pelvic floor muscles, fecal or urinary stress incontinence and constipation.

Precautions: the device is to be used only following doctor’s advice/guidance and only after proper training.

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About us

Company details

BIONEN is an Italian company manufacturing medical accessories for neurophysiology since 1989. The complete product portfolio is designed and manufactured in Italy and mainly includes needles and surface electrodes to perform neurophysiological examinations, like muscle activity registration (EMG) and brain activity registration (EEG).
Our team is flexible, skilled and ready to manufacture custom products to satisfy all needs of our customers.

Our Company Quality System complies with the European Standard ISO 13485:2012 which specifies the guidelines for application of the ISO 9001 standards in R&D, design, manufacturing, installation, and service of medical devices.

All our products are CE certifiied according to the MDD 93/42/ECC and its revised version and a part of them according to the FDA Quality Systems Regulation 21 CFR.820.

We always control the bioburden contamination level of products that need to be sterilized, and to guarantee the maintainance of a minimum level of contamination some critical steps of the manufacturing process are made in a Clean Room (ISO 8).

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