FDA Device Establishments · JSON-LD · Markdown
FEI 3010762896 · Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3010762896 |
|---|---|
| Owner / Operator | Neuroelectrics Barcelona, S.L.U. (#10055170) |
| Address | Av Tibidabo, 47 Bis, Barcelona Catalonia, 08035, ES |
| Mandatory US Agent | Neuroelectrics USA Corporation |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | GWQ, GWL |
| Regulation § (21 CFR) | 882.1400, 882.1835 |
| Proprietary names | Enobio Dx 8; Enobio Dx 20; Enobio Dx 32 |
Source: openFDA. Public-domain (CC0).