FDA device listing
Assura Irrigation Pressplate,Assura Irrigation Set,Coloplast Irrigation Colotip,Coloplast Irrigation Set Kit,SenSura Mio…
FDA device listing 1100181905 · Coloplast Corp.
Key facts
| Proprietary names | Assura Irrigation Pressplate,Assura Irrigation Set,Coloplast Irrigation Colotip,Coloplast Irrigation Set Kit,SenSura Mio Hospital Irrigation Set,SenSura Mio Irrigation Sleeve,Sensura Mio Irrigation Sleeves |
|---|---|
| Owner/operator | Coloplast Corp. |
| Owner/operator number | 8010144 |
| Premarket submissions | K121833 |
| Product codes | EXD |
| Device names | EXD - Irrigator, Ostomy |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5895 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | COLOPLAST A/S, COLOPLAST HUNGARY KFT, Coloplast Manufacturing US, LLC. |
| Establishment registrations | 9610694, 3003814961, 3030087693 |
| FEI numbers | 3002806731, 3003814961, 3030087693 |
| Establishment operations | Manufacturer, Repackager/Relabeler, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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