FDA Device Establishments · JSON-LD · Markdown
FEI 3034211447 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device · Status: Active
| FEI Number | 3034211447 |
|---|---|
| Owner / Operator | Onward Medical (#10092025) |
| Address | Schimmelt 2, Eindhoven Noord-Brabant, 5611 ZX, NL |
| Mandatory US Agent | ONWARD Medical Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | SDO |
| Regulation § (21 CFR) | 890.5851 |
| Proprietary names | ARC-EX System - Professional US |
Source: openFDA. Public-domain (CC0).