FDA Device Establishments · JSON-LD · Markdown
FEI 3016450067 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3016450067 |
|---|---|
| Owner / Operator | Thora Tech GmbH (#10087914) |
| Address | Gutfleischstr. 3-5, Giesen Lower Saxony, 35390, DE |
| Mandatory US Agent | Imagenix, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | BTT, CBK |
| Regulation § (21 CFR) | 868.5450, 868.5895 |
| Proprietary names | Monsoon Critical Care Jet Ventilator; LaserJet Catheter |
Source: openFDA. Public-domain (CC0).