FDA Device Establishments · JSON-LD · Markdown
FEI 3009471886 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active
| FEI Number | 3009471886 |
|---|---|
| Owner / Operator | AGFA HEALTHCARE N.V. (#9011611) |
| Address | SEPTESTRAAT 27, MORTSEL Antwerpen, B 2640, BE |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LLZ |
| Regulation § (21 CFR) | 892.2050 |
| Proprietary names | IMPAX; MA3000; Impax for Breast Imaging |
Source: openFDA. Public-domain (CC0).