FDA Device Establishments · JSON-LD · Markdown
FEI 3011802635 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3011802635 |
|---|---|
| Owner / Operator | KIRO GRIFOLS, S.L. (#10049581) |
| Address | Polo de Innovacion Garaia, Goiru Kalea 1, Edificio B, Arrasate-Mondragon Guipuzcoa, 20500, ES |
| Mandatory US Agent | Grifols USA, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NEP |
| Regulation § (21 CFR) | 880.5440 |
| Proprietary names | KIRO Oncology US; KIRO Link; KIRO Fill US |
Source: openFDA. Public-domain (CC0).