FDA Device Establishments · JSON-LD · Markdown
FEI 3014032451 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3014032451 |
|---|---|
| Owner / Operator | Utitec Medical S.A. dba Cadence Costa Rica (#10056426) |
| Address | Zona Franca Coyol, Alajuela., Building N. 15, El Coyol Alajuela, 506, CR |
| Mandatory US Agent | Cadence Inc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KNW |
| Regulation § (21 CFR) | 876.1075 |
| Proprietary names | Brevera Biopsy System with CorLumina Technology; Brevera Breast Biopsy System |
Source: openFDA. Public-domain (CC0).