FDA Device Establishments · JSON-LD · Markdown
FEI 3014133483 · Sterilize Medical Device for Another Party (Contract Sterilizer) Develop Specifications But Do Not Manufacture At This Facility Remanufacture Medical Device Reprocess Single-Use Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198 Repack or Relabel Medical Device Foreign Private Label Distributor Export Device to the United States But Perform No Other Operation on Device Manufacture Medical Device · Status: Active
| FEI Number | 3014133483 |
|---|---|
| Owner / Operator | ATEX Co., Ltd. (#10060111) |
| Address | 3-3-24 Nagayoshi-kawanabe, Hirano-ku, Osaka, 547-0014, JP |
| Mandatory US Agent | FIUS Distributors, LLC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | ISA |
| Regulation § (21 CFR) | 890.5660 |
| Proprietary names | Lourdes; OHCO |
Source: openFDA. Public-domain (CC0).