FDA Device Establishments · JSON-LD · Markdown
FEI 3017140456 · Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3017140456 |
|---|---|
| Owner / Operator | Fuji Latex Co., LTD. (#10029059) |
| Address | 1705 CHIZUKA-MACHI, Chizuka, Tochigi, 328-0135, JP |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | ITX, EOQ |
| Regulation § (21 CFR) | 892.1570, 874.4680 |
| Proprietary names | PENTAX Single Use Balloon OE-A52 |
Source: openFDA. Public-domain (CC0).