FDA Device Establishments · JSON-LD · Markdown
FEI 3018064242 · Manufacture Medical Device · Status: Active
| FEI Number | 3018064242 |
|---|---|
| Owner / Operator | Disior Oy (#10077636) |
| Address | HTC Helsinki, Building Pinta, Tammasaarenkatu 3, Helsinki Uusimaa, 00180, FI |
| Mandatory US Agent | PARAGON28 |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | QIH |
| Regulation § (21 CFR) | 892.2050 |
| Proprietary names | SMART Bun-Yo-Matic CT |
Source: openFDA. Public-domain (CC0).