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Sign in to claim this brandVisby Medical, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 3010 North First Street, San Jose, CA, 95134
- Website
- —
- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3016608638
- DUNS Number
- 933894748
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Visby Medical Flu and COVID-19 Test | K253971 | FDA 510(k) | N/A | Active |
| Visby Medical Sexual Health Click Test | 000175 | FDA UDI | Class II | Unknown |
| Visby Medical Respiratory Health | PS-300708 | FDA UDI | Class II | Active |
| Visby Medical Sexual Health Test | PS-001402 | FDA UDI | Class II | Active |
| Visby Medical Sexual Health Vaginal Specimen Collection Kit, 50 Pack | PS-000715 | FDA UDI | Class II | Active |
| Visby Medical Power Adapter | PS-000288 | FDA UDI | Class II | Active |
| Visby Medical Women's Sexual Health Test | PS-400145 | FDA UDI | Class II | Active |
| Visby Medical Power Adapter, Right Angle | PS-000855 | FDA UDI | Class II | Active |
| Visby Medical Sexual Health Test | K220407 | FDA 510(k) | Class II | Active |
| Visby Medical Sexual Health | K200748 | FDA 510(k) | Class II | Active |
| Visby Medical Men's Sexual Health Test | K251501 | FDA 510(k) | Class II | Active |
| Visby Medical Respiratory Health Test | K242526 | FDA 510(k) | Class II | Active |
| Visby Medical Women's Sexual Health Test | DEN240020 | FDA 510(k) | Class II | Active |
Related Companies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 5, 2020 | Z-0847-2021 | — | terminated | Two issues: 1) 5 Lots were found to have incorrect labeling on the outer box stating that the product is CLIA Waived. 2) 3 Lots contain a kit component that expires prior to the expiration date on the test kits. |