FDA Device Establishments · JSON-LD · Markdown
FEI 3029906968 · Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3029906968 |
|---|---|
| Owner / Operator | Oivi AS (#10088795) |
| Address | Gaustadalleen 21, Oslo, 0349, NO |
| Mandatory US Agent | QA/RA CONSULTING GROUP, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PJZ |
| Regulation § (21 CFR) | 886.1120 |
| Proprietary names | OFC100L, Oivi Fundus Camera |
Source: openFDA. Public-domain (CC0).