FDA Device Establishments · JSON-LD · Markdown
FEI 3013634084 · Manufacture Medical Device · Status: Active
| FEI Number | 3013634084 |
|---|---|
| Owner / Operator | SIS Medical AG (#10086262) |
| Address | Hungerbueelstr. 12A, Frauenfeld Thurgau, 8500, CH |
| Mandatory US Agent | CardioMed Device Consultants, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | LOX |
| Regulation § (21 CFR) | 870.5100 |
| Proprietary names | OPN NC PTCA Dilatation Catheter |
Source: openFDA. Public-domain (CC0).