FDA Device Establishments · JSON-LD · Markdown
FEI 3002806883 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3002806883 |
|---|---|
| Owner / Operator | ELEKTA AB (#8030893) |
| Address | Hagaplan 4, Stockholm, 11368, SE |
| Mandatory US Agent | Elekta |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | IWB, MUJ |
| Regulation § (21 CFR) | 892.5750, 892.5050 |
| Proprietary names | Leksell GammaPlan (LGP) 11.4 |
Source: openFDA. Public-domain (CC0).