FDA Device Establishments · JSON-LD · Markdown
FEI 3003678543 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3003678543 |
|---|---|
| Owner / Operator | Biomerics (#10042380) |
| Address | SARET INDUSTRIAL PARK, BLDG. D-3, C-7, C-2/C-3, C-4, E-2, ALAJUELA, 4002, CR |
| Mandatory US Agent | Biomerics |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GEH |
| Regulation § (21 CFR) | 878.4350 |
| Proprietary names | XSense Cryoablation System with Cryoprobes |
Source: openFDA. Public-domain (CC0).