FDA device listing
EasiVac
FDA device listing 1750251538 · Coloplast Corp.
Key facts
| Proprietary names | EasiVac |
|---|---|
| Owner/operator | Coloplast Corp. |
| Owner/operator number | 8010144 |
| Product codes | FFD |
| Device names | FFD - Evacuator, Bladder, Manually Operated |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.4370 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Centre de distribution Coloplast Le Plessis Pate, COLOPLAST MANUFACTURING FRANCE, SAS |
| Establishment registrations | 9610711, 3012649202 |
| FEI numbers | 3002807917, 3012649202 |
| Establishment operations | Foreign Exporter, Specification Developer |
| 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