FDA Device Establishments · JSON-LD · Markdown
FEI 3007710603 · Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility · Status: Active
| FEI Number | 3007710603 |
|---|---|
| Owner / Operator | XVIVO Perfusion AB (#10029831) |
| Address | Entreprenorsstraket 10, Molndal Vastra Gotaland, 43153, SE |
| Mandatory US Agent | XVIVO Perfusion INC |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 1 |
| Product codes (top 20) | PHO |
| Proprietary names | XVIVO Lung Cannula Set; XVIVO Organ Chamber; XVIVO PGM; XPS; XVIVO Disposable Kit; XPS Disposable Lung Circuit; STEEN Solution |
Source: openFDA. Public-domain (CC0).