Data / Medical devices / Spain / Neuroelectrics Barcelona S.L.U.
Neuroelectrics Barcelona S.L.U.: FDA-registered device maker in Barcelona Catalonia, Spain, 1 510(k) clearance
Neuroelectrics Barcelona S.L.U. is registered with the FDA (registration 3010762896) in Barcelona Catalonia, Spain. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010762896
- Address
- Av Tibidabo, 47 Bis, Barcelona Catalonia, Spain, 08035
- Owner or operator
- Neuroelectrics Barcelona, S.L.U. (10055170)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- September 16, 2026
- Registered through
- 2026
- Brand names listed
- Enobio Dx 20, Enobio Dx 32, Enobio Dx 8
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Amplifier, Physiological Signal | GWL | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 13, 2026 | K261604 | Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) | GWQ | Substantially Equivalent | Neuroelectrics Barcelona S.L.U. | accessdata.fda.gov |
Compare with other makers
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Electrode, Cutaneous
- All makers of Amplifier, Physiological Signal
Updated June 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.