FDA Device Establishments · JSON-LD · Markdown
FEI 3001427085 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3001427085 |
|---|---|
| Owner / Operator | BYTEC MEDIZINTECHNIK GMBH (#10023741) |
| Address | Hermann-Hollerith-Str. 11, Eschweiler North Rhine-Westphalia, 52249, DE |
| Mandatory US Agent | ACIST Medical Systems, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IZQ |
| Regulation § (21 CFR) | 870.1650 |
| Proprietary names | EmpowerMR Injector System |
Source: openFDA. Public-domain (CC0).