FDA Device Establishments · JSON-LD · Markdown
FEI 3005622096 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3005622096 |
|---|---|
| Owner / Operator | Otsuka Electronics Co.,Ltd (#10095518) |
| Address | 1-10, Sasagaoka, Minakuchi-cho, Koka-city Shiga, 528-0061, JP |
| Mandatory US Agent | FUJIREBIO DIAGNOSTICS, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 3 |
| Product codes (top 20) | JIT, LTK, JJE |
| Regulation § (21 CFR) | 862.1150, 866.6010, 862.2160 |
| Proprietary names | Lumipulse G1200 Instrument |
Source: openFDA. Public-domain (CC0).