FDA Device Establishments · JSON-LD · Markdown
FEI 3016608638 · Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198 · Status: Active
| FEI Number | 3016608638 |
|---|---|
| Owner / Operator | Visby Medical, Inc. (#10080245) |
| Address | 3010 North First Street, San Jose, CA, US |
| Registration expiry | 2026 |
| Initial importer flag | N |
| Registered products | 4 |
| Product codes (top 20) | OUY, LSL, QEP, MKZ |
| Regulation § (21 CFR) | 866.3860, 866.3390, 866.3393, 866.3120 |
| Proprietary names | Visby Medical Sexual Health Click Test |
Source: openFDA. Public-domain (CC0).