FDA Device Establishments · JSON-LD · Markdown
FEI 3016447772 · Export Device to the United States But Perform No Other Operation on Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3016447772 |
|---|---|
| Owner / Operator | Urosystem Zrt (#10062314) |
| Address | Szent Istvan park 26, Budapest, 1137, HU |
| Mandatory US Agent | MedTech Review, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KOA |
| Regulation § (21 CFR) | 876.4730 |
| Proprietary names | UroDapter / MID-ii |
Source: openFDA. Public-domain (CC0).