FDA Device Establishments · JSON-LD · Markdown
FEI 3011047165 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3011047165 |
|---|---|
| Owner / Operator | Kvikna Medical ehf (#10051556) |
| Address | Lynghals 9, Reykjavik, 110, IS |
| Mandatory US Agent | Stratus |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | GWQ, OLT |
| Regulation § (21 CFR) | 882.1400 |
| Proprietary names | Stratus EEG |
Source: openFDA. Public-domain (CC0).