FDA Device Establishments · JSON-LD · Markdown
FEI 3003044483 · Manufacture Medical Device · Status: Active
| FEI Number | 3003044483 |
|---|---|
| Owner / Operator | HemoCue AB (#9099323) |
| Address | KUVETTGATAN 1, ANGELHOLM Skane, SE-262 71, SE |
| Mandatory US Agent | Radiometer America Inc. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GKR |
| Regulation § (21 CFR) | 864.5620 |
| Proprietary names | HemoCue Hb 301 System |
Source: openFDA. Public-domain (CC0).