FDA Device Establishments · JSON-LD · Markdown
FEI 3010063021 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3010063021 |
|---|---|
| Owner / Operator | TNI medical AG (#10051448) |
| Address | Nurnberger Str. 74a, Wurzburg Bavaria, 97076, DE |
| Mandatory US Agent | Masimo Corporation |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | BTT |
| Regulation § (21 CFR) | 868.5450 |
| Proprietary names | TNI softFlow 50 Hospital System 10-50L |
Source: openFDA. Public-domain (CC0).