FDA Device Establishments · JSON-LD · Markdown
FEI 3010421384 · Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3010421384 |
|---|---|
| Owner / Operator | SYSMEX CORPORATION (#9014170) |
| Address | 4-4-4 TAKATSUKADAI NISHI-KU, KOBE Hyogo, 651-2271, JP |
| Mandatory US Agent | SYSMEX AMERICA, INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | GKZ |
| Regulation § (21 CFR) | 864.5220 |
| Proprietary names | Sysmex XR-Series (XR-10) Automated Hematology Analyzer |
Source: openFDA. Public-domain (CC0).