FDA Device Establishments · JSON-LD · Markdown
FEI 3014926240 · Manufacture Medical Device · Status: Active
| FEI Number | 3014926240 |
|---|---|
| Owner / Operator | Topcon Healthcare Solutions EMEA Oy (#10058704) |
| Address | Saaristonkatu 9, OULU Pohjois-Pohjanmaa, 90100, FI |
| Mandatory US Agent | Topcon Healthcare, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | OUG |
| Regulation § (21 CFR) | 880.6310 |
| Proprietary names | Optoflow; Harmony One; Harmony Plus; Harmony Referral System; RDx |
Source: openFDA. Public-domain (CC0).