FDA Device Establishments · JSON-LD · Markdown
FEI 1000487132 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 1000487132 |
|---|---|
| Owner / Operator | OEM SYSTEMS CO. LTD. (#9050895) |
| Address | 84 MEKAWA MAKISHIMA-CHO, UJI-SHI Kyoto, 6110041, JP |
| Mandatory US Agent | Ken Block Consulting |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | JPD, LCP |
| Regulation § (21 CFR) | 864.7400, 864.7470 |
| Proprietary names | Variant II Hemoglobin System |
Source: openFDA. Public-domain (CC0).