FDA Device Establishments · JSON-LD · Markdown
FEI 3007674911 · Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3007674911 |
|---|---|
| Owner / Operator | Hyperion Medical (#10033629) |
| Address | 15932 MIDWAY RD, ADDISON, TX, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ISA |
| Regulation § (21 CFR) | 890.5660 |
| Proprietary names | Smart-RST |
Source: openFDA. Public-domain (CC0).