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Sign in to claim this brandBIONEN SAS DI BARBARA NENCIONI & C.
US
Last updated May 23, 2026
What BIONEN SAS DI BARBARA NENCIONI & C. makes
The company manufactures single-use electromyographic needle electrodes, designed for diagnostic procedures involving muscle and nerve assessments. These electrodes are intended for temporary insertion into tissue to measure electrical activity, aiding in the evaluation of neuromuscular conditions.
The product portfolio is classified as Class II under FDA regulations and is listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does BIONEN SAS DI BARBARA NENCIONI & C. manufacture?
BIONEN SAS DI BARBARA NENCIONI & C. specializes in single-use electromyographic needle electrodes. These devices are specifically designed for diagnostic procedures that involve assessing muscle and nerve function by measuring electrical activity during temporary tissue insertion. They are used in evaluating neuromuscular conditions.
Where is BIONEN SAS DI BARBARA NENCIONI & C. based?
The company is based in the United States. This location is relevant for understanding regulatory oversight and compliance, as it operates under the jurisdiction of the FDA.
Which regulatory registries list the devices manufactured by BIONEN SAS DI BARBARA NENCIONI & C.?
The devices produced by BIONEN SAS DI BARBARA NENCIONI & C. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps ensure traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify device details.
How are the devices manufactured by BIONEN SAS DI BARBARA NENCIONI & C. classified under FDA regulations?
The electromyographic needle electrodes produced by BIONEN SAS DI BARBARA NENCIONI & C. fall under Class II classification according to FDA regulations. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, beyond general controls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 444022750
Catalogue (17)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bionen | 0028524 | FDA UDI | Class II | Active |
| Bionen | 0028526 | FDA UDI | Class II | Active |
| Bionen | 0028013 | FDA UDI | Class II | Active |
| Bionen | 0028112 | FDA UDI | Class II | Active |
| Bionen | 0028113 | FDA UDI | Class II | Active |
| Bionen | 0028017 | FDA UDI | Class II | Active |
| Bionen | 0028525 | FDA UDI | Class II | Active |
| Bionen | 0028016 | FDA UDI | Class II | Active |
| Bionen | 0028523 | FDA UDI | Class II | Active |
| Bionen | 0028012 | FDA UDI | Class II | Active |
| Bionen | 0028522 | FDA UDI | Class II | Active |
| Bionen | 0028015 | FDA UDI | Class II | Active |
| Bionen | 0028018 | FDA UDI | Class II | Active |
| Bionen | 0028527 | FDA UDI | Class II | Active |
| Bionen | 0028014 | FDA UDI | Class II | Active |
| Bionen | 0028528 | FDA UDI | Class II | Active |
| Bionen | 0028521 | FDA UDI | Class II | Active |
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