FDA Device Establishments · JSON-LD · Markdown
FEI 3004941544 · Remanufacture Medical Device Reprocess Single-Use Device Sterilize Medical Device for Another Party (Contract Sterilizer) Develop Specifications But Do Not Manufacture At This Facility Foreign Private Label Distributor Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) · Status: Active
| FEI Number | 3004941544 |
|---|---|
| Owner / Operator | COSMOTEC SUPPLY (#9069279) |
| Address | 1-511 Nakano, Fukui, 918-8186, JP |
| Mandatory US Agent | OGI, LLC. |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | HQZ |
| Regulation § (21 CFR) | 886.5842 |
| Proprietary names | OGI; RED ROSE |
Source: openFDA. Public-domain (CC0).