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Sign in to claim this brandNEUROELECTRICS BARCELONA SL
US
Last updated May 30, 2026
What NEUROELECTRICS BARCELONA SL makes
The company manufactures electroencephalographic (EEG) monitoring systems designed for clinical use, including the Enobio Dx device. These systems are intended for recording and analyzing brain electrical activity, supporting diagnostic and research applications in neurological assessments.
The Enobio Dx falls under Class II regulatory classification and is listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States, adhering to applicable regulatory standards for medical devices in that jurisdiction.
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 Neuroelectrics Barcelona SL primarily manufacture?
Neuroelectrics Barcelona SL specializes in electroencephalographic (EEG) monitoring systems, specifically designed for clinical use. Their primary product, the Enobio Dx, is an EEG device used to record and analyze brain electrical activity. These systems are intended for diagnostic and research purposes in neurological assessments.
Where is Neuroelectrics Barcelona SL based, and what regulatory jurisdiction does it operate under?
Neuroelectrics Barcelona SL is based in the United States. As a manufacturer, it operates under the regulatory standards applicable to medical devices in the U.S., ensuring compliance with relevant authorities like the FDA for its Class II devices.
Which regulatory registries or databases list Neuroelectrics Barcelona SL’s devices?
The Enobio Dx device from Neuroelectrics Barcelona SL is listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices authorized for use in the U.S., ensuring transparency and traceability.
How are Neuroelectrics Barcelona SL’s devices classified under U.S. regulations?
Neuroelectrics Barcelona SL’s Enobio Dx device falls under Class II regulatory classification in the U.S. This classification is assigned based on the device’s risk level and intended use, requiring compliance with specific controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- neuroelectrics.com
- —
- —
- [email protected]
- Phone
- +34 932540366
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 463756944
Catalogue (20)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Enobio | WF | FDA UDI | Class II | Unknown |
| Enobio Dx | NG Pistim - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Neoprene Headcap (size M) - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Neoprene Headcap (size XL) - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Foretrode - Component Replacement: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Neoprene Headcap (size S) - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Enobio Dx 8 | FDA UDI | Class II | Active |
| Enobio Dx | Enobio Dx 32 | FDA UDI | Class II | Active |
| Enobio Dx | Earclip - Component Replacement: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Neoprene Headcap (size L) - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Kid Neoprene Headcap (size K) - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Kid Neoprene Headcap (size KS) - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Enobio Dx 20 | FDA UDI | Class II | Active |
| Enobio Dx | NG Geltrode - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Neoprene Headband - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Foretrode - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Neoprene Headcap (Kit, size M) - Component Replacement: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | NG Geltrode - Component Replacement: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | NG Pistim - Component Replacement: Enobio Dx | FDA UDI | Class II | Active |
| Enobio Dx | Drytrode - Component Spare Part: Enobio Dx | FDA UDI | Class II | Active |
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