FDA Device Establishments · JSON-LD · Markdown
FEI 3042928350 · Complaint File Establishment per 21 CFR 820.198 Foreign Private Label Distributor Develop Specifications But Do Not Manufacture At This Facility Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3042928350 |
|---|---|
| Owner / Operator | Computer Vision AG (#10094920) |
| Address | Zwicky-Platz 1, Wallisellen Zurich, 8304, CH |
| Mandatory US Agent | Emeralgo Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QIH |
| Regulation § (21 CFR) | 892.2050 |
| Proprietary names | Emeralgo Ortho L-Spine MR-Q |
Source: openFDA. Public-domain (CC0).