FDA Device Establishments · JSON-LD · Markdown
FEI 1000477110 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 1000477110 |
|---|---|
| Owner / Operator | Convatec, Inc. (#8021535) |
| Address | Aaholmvej 1 - 3, OSTED, LEJRE Sjalland, 4320, DK |
| Mandatory US Agent | ConvaTec |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | FPA |
| Regulation § (21 CFR) | 880.5440 |
| Proprietary names | MiniMed Mio Infusion set; Quick-set® Paradigm®; Mio®; MiniMed Sure T Infusion set; MiniMed Quick set Infusion set; Sure-T® Paradigm® |
Source: openFDA. Public-domain (CC0).