FDA Device Establishments · JSON-LD · Markdown
FEI 3012120143 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Manufacture Medical Device · Status: Active
| FEI Number | 3012120143 |
|---|---|
| Owner / Operator | IMBiotechnologies Ltd (#10051764) |
| Address | 9650 20th Avenue, NW, Suite 215, Edmonton Alberta, T6N 1G1, CA |
| Mandatory US Agent | ICON plc |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | KRD |
| Regulation § (21 CFR) | 870.3300 |
| Proprietary names | Occlusin 500 Artificial Embolization Device; Ekobi Embolization Microspheres |
Source: openFDA. Public-domain (CC0).