FDA Device Establishments · JSON-LD · Markdown
FEI 3011724582 · Manufacture Medical Device · Status: Active
| FEI Number | 3011724582 |
|---|---|
| Owner / Operator | MATERIALISE N.V. (#9029485) |
| Address | Calle 29, 41-105, Loma San Julian, Edificio Soho, interior 401, Medellin Antioquia, 050021, CO |
| 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 Glenoid Positioning System; Materialise Glenoid Positioning System guides; Materialise Shoulder Guide and Models; Lima Personalized Surgical Instruments; TruMatch Personalized Solutions Shoulder Guide; SurgiCase Planner; SurgiCase Shoulder Planner; Materialise SurgiCase Planner; Match Point System; Materialise Shoulder Planner |
Source: openFDA. Public-domain (CC0).