FDA Device Establishments · JSON-LD · Markdown
FEI 1528028 · Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 1528028 |
|---|---|
| Owner / Operator | FUJIFILM Healthcare Americas Corporation (#10082284) |
| Address | 1959 Summit Commerce Park, Twinsburg, OH, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 3 |
| Product codes (top 20) | IYN, ITX, IYO |
| Regulation § (21 CFR) | 892.1550, 892.1570, 892.1560 |
| Proprietary names | S12BP4 Neurosurgery Probe; UST-9150 |
Source: openFDA. Public-domain (CC0).