FDA Device Establishments · JSON-LD · Markdown
FEI 3003998208 · Manufacture Medical Device · Status: Active
| FEI Number | 3003998208 |
|---|---|
| Owner / Operator | MATERIALISE N.V. (#9029485) |
| Address | 15 TECHNOLOGIELAAN, LEUVEN Vlaams Brabant, 3001, BE |
| Mandatory US Agent | Materialise USA |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | OOG, HSX |
| Regulation § (21 CFR) | 888.3560, 888.3520 |
| Proprietary names | Materialise PKA Guide System; Zimmer Patient Specific Instruments Planner; SurgiCase Knee Planner; Zimmer Patient Specific Instruments; Zimmer Biomet Patient Specific Instruments; Signature Guides; Materialise PKA Guides; Signature Planner |
Source: openFDA. Public-domain (CC0).