FDA device listing
VitaSmart Hypothermic Oxygenated Perfusion System
FDA device listing 1541438899 · Medica S.p.A.
Key facts
| Proprietary names | VitaSmart Hypothermic Oxygenated Perfusion System |
|---|---|
| Owner/operator | Medica S.p.A. |
| Owner/operator number | 9040626 |
| Product codes | SGY |
| Device names | SGY - Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5881 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Medica S.p.A. |
| Establishment registrations | 9615942 |
| FEI numbers | 1000191953 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database