FDA Device Establishments · JSON-LD · Markdown
FEI 3009307953 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3009307953 |
|---|---|
| Owner / Operator | DEMANT A/S (#8010048) |
| Address | ul. Lubieszynska 59, Mierzyn Zachodniopomorskie, 72-006, PL |
| Mandatory US Agent | Oticon Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | MAH |
| Regulation § (21 CFR) | 874.3302 |
| Proprietary names | Ponto BHX Implant, 3 mm, with abutment, 9 mm; Soft healing cap; Ponto BHX Implant, 4 mm, with abutment, 12 mm; Ponto BHX Implant, 4 mm; Ponto BHX Implant, 4 mm, with abutment, 14 mm; Ponto BHX Implant, 4 mm, with abutment, 6 mm; Double-ended dissector; MIPS Back-up kit, 3 mm; Ponto BHX Implant, 3 mm, with abutment, 6 mm; Ponto BHX Implant, 4 mm, with abutment, 9 mm |
Source: openFDA. Public-domain (CC0).