FDA Device Establishments · JSON-LD · Markdown
FEI 3005739556 · Manufacture Medical Device · Status: Active
| FEI Number | 3005739556 |
|---|---|
| Owner / Operator | DUPHAMED B.V. (#9087279) |
| Address | Jac.P.Thijsseweg 12, ALPHEN AAN DEN RIJN Zuid-Holland, 2408 ER, NL |
| Mandatory US Agent | MDI Consultants, Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EGZ |
| Regulation § (21 CFR) | 872.1905 |
| Proprietary names | Foam Bites for edentulous patient; wall mount for digital x-ray intraoral sensor; phosphor plate positioners, intraoral, Bite wing/Posterior/Periapical/Endo, size 1 and 2; OPG head support strip; digital sensor hygiene sleeve/barrier, several sizes; phosphor plate positioner kit; phosphor plate hygiene sleeve/barrier, sizes 0, 1, 2, 3 and 4; hygiene sleeve/barrier for ear cone, cephalometric imaging; digital sensor positioners, intraoral, Bite wing/Posterior/Periapical/Endo, size 1 and 2; OPG bite block sleeve |
Source: openFDA. Public-domain (CC0).