FDA Device Establishments · JSON-LD · Markdown
FEI 3026391019 · Manufacture Medical Device · Status: Active
| FEI Number | 3026391019 |
|---|---|
| Owner / Operator | Image Instruments GmbH (#10087224) |
| Address | Niederwaldstr. 3, Chemnitz Saxony, 09123, DE |
| Mandatory US Agent | Regulatory Specialists, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | LLZ, PNN |
| Regulation § (21 CFR) | 892.2050, 872.5470 |
| Proprietary names | OnyxCeph |
Source: openFDA. Public-domain (CC0).