FDA Device Establishments · JSON-LD · Markdown
FEI 3003630693 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device · Status: Active
| FEI Number | 3003630693 |
|---|---|
| Owner / Operator | CellaVision AB (#9043433) |
| Address | Mobilvagen 12, LUND Skane, SE-22362, SE |
| Mandatory US Agent | - |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 2 |
| Product codes (top 20) | GKZ, JOY |
| Regulation § (21 CFR) | 864.5220, 864.5260 |
| Proprietary names | CellaVision DM96 |
Source: openFDA. Public-domain (CC0).