FDA Device Establishments · JSON-LD · Markdown
FEI 3039487170 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3039487170 |
|---|---|
| Owner / Operator | Helio Diagnostics SAS (#10093994) |
| Address | 163 avenue de Luminy, Marseille Bouches-du-Rhone, 13009, FR |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | NYI |
| Regulation § (21 CFR) | 866.6040 |
| Proprietary names | Prosigna Breast Cancer Assay |
Source: openFDA. Public-domain (CC0).