FDA Device Establishments · JSON-LD · Markdown
FEI 1821514 · Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device · Status: Active
| FEI Number | 1821514 |
|---|---|
| Owner / Operator | Kulzer, LLC (#9056636) |
| Address | 4315 S. Lafayette Blvd., SOUTH BEND, IN, US |
| Registration expiry | 2026 |
| Initial importer flag | Y |
| Registered products | 1 |
| Product codes (top 20) | EMA |
| Regulation § (21 CFR) | 872.3275 |
| Proprietary names | iCEM Universal Plus |
Source: openFDA. Public-domain (CC0).