FDA Device Establishments · JSON-LD · Markdown
FEI 3009555440 · Manufacture Medical Device · Status: Active
| FEI Number | 3009555440 |
|---|---|
| Owner / Operator | MATERIALISE N.V. (#9029485) |
| Address | Raisy Okipnoy str., 8A, Kyiv Kyyiv, Misto, 02002, UA |
| Mandatory US Agent | Materialise USA |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | QHE, PHX, KWS |
| Regulation § (21 CFR) | 888.3660 |
| Proprietary names | Materialise SurgiCase Planner; Materialise Shoulder Planner; Materialise Glenoid Positioning System guides; Match Point System; Lima Personalized Surgical Instruments; AtlasPlan Shoulder System; SurgiCase Planner; TruMatch Personalized Solutions Shoulder Guide; Materialise Glenoid Positioning System; SurgiCase Shoulder Planner |
Source: openFDA. Public-domain (CC0).