FDA Device Establishments · JSON-LD · Markdown
FEI 3004070020 · Manufacture Medical Device · Status: Active
| FEI Number | 3004070020 |
|---|---|
| Owner / Operator | OSSTELL AB (#9059818) |
| Address | Stampgaten 14, GOTEBORG Vastra Gotaland, 41101, SE |
| Mandatory US Agent | Pro Pharma Group |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EKX |
| Regulation § (21 CFR) | 872.4200 |
| Proprietary names | Mega ISQ II; Beacon; Smart Pegs Type 1- 115; NeoTell, Osstell Classic; ISQTracker; SmartPeg Type 117, 127, 137 |
Source: openFDA. Public-domain (CC0).