FDA Device Establishments · JSON-LD · Markdown
FEI 1000369487 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 1000369487 |
|---|---|
| Owner / Operator | 77 Elektronika Kft. (#10041281) |
| Address | Fehervari ut 98., Budapest, 1116, HU |
| Mandatory US Agent | Roche Diagnostics Operations Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | KHE, KQO |
| Regulation § (21 CFR) | 864.6550, 862.2900 |
| Proprietary names | Urisys 1100 |
Source: openFDA. Public-domain (CC0).