FDA Device Establishments · JSON-LD · Markdown
FEI 3004008703 · Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3004008703 |
|---|---|
| Owner / Operator | Boule Diagnostics AB (#9034165) |
| Address | Fagerstagatan 7, Spanga Stockholm, 163 53, SE |
| Mandatory US Agent | Clinical Diagnostics Solutions |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GKZ |
| Regulation § (21 CFR) | 864.5220 |
| Proprietary names | Medonic M-series |
Source: openFDA. Public-domain (CC0).