FDA Device Establishments · JSON-LD · Markdown
FEI 3001556265 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3001556265 |
|---|---|
| Owner / Operator | Agfa N.V. (#10058267) |
| Address | Septestraat 27, Mortsel Antwerpen, B-2640, BE |
| Mandatory US Agent | Agfa US Corp |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LHO |
| Regulation § (21 CFR) | 892.1940 |
| Proprietary names | Auto QC2 Mammography; NX 3 |
Source: openFDA. Public-domain (CC0).