FDA Device Establishments · JSON-LD · Markdown
FEI 3016261803 · Manufacture Medical Device · Status: Active
| FEI Number | 3016261803 |
|---|---|
| Owner / Operator | BIOPTIMAL INTERNATIONAL PTE LTD (#9004883) |
| Address | 14 Kaki Bukit View, SINGAPORE South East, 415950, SG |
| Mandatory US Agent | BIOMEDICAL SALES INTERNATIONAL, INC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | EZL |
| Regulation § (21 CFR) | 876.5130 |
| Proprietary names | Silicon Foley Catheter |
Source: openFDA. Public-domain (CC0).