FDA Device Establishments · JSON-LD · Markdown
FEI 3001587388 · Manufacture Medical Device · Status: Active
| FEI Number | 3001587388 |
|---|---|
| Owner / Operator | SOPHYSA (#10023919) |
| Address | Rue Sophie Germain, Technopole TEMIS, BESANCON Doubs, 25000, FR |
| Mandatory US Agent | Sophysa USA Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GWM |
| Regulation § (21 CFR) | 882.1620 |
| Proprietary names | Pressio 2 ICP monitoring system |
Source: openFDA. Public-domain (CC0).