FDA Device Establishments · JSON-LD · Markdown
FEI 3004423487 · Foreign Private Label Distributor Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3004423487 |
|---|---|
| Owner / Operator | Prollenium Medical Technologies Inc. (#10055618) |
| Address | 138 Industrial Pkwy N., Aurora Ontario, L4G4C3, CA |
| Mandatory US Agent | Emergo Global Representation LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | IME |
| Regulation § (21 CFR) | 890.5700 |
| Proprietary names | Revanesse Gel Pack |
Source: openFDA. Public-domain (CC0).