FDA Device Establishments · JSON-LD · Markdown
FEI 1000117361 · Manufacture Medical Device · Status: Active
| FEI Number | 1000117361 |
|---|---|
| Owner / Operator | ENCISION, INC. (#9003185) |
| Address | 6797 WINCHESTER CIR., BOULDER, CO, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | GEI |
| Regulation § (21 CFR) | 878.4400 |
| Proprietary names | AEM Endoshield 2 Burn Protection System; EM200 |
Source: openFDA. Public-domain (CC0).