FDA device listing
Assura 1pc Kit,Assura CV Kit,Assura Kit,Assura Night bag,Assura Ostomy Pouch,Assura Urostomy bag,Assura Urostomy…
FDA device listing 1471863104 · Coloplast Corp.
Key facts
| Proprietary names | Assura 1pc Kit,Assura CV Kit,Assura Kit,Assura Night bag,Assura Ostomy Pouch,Assura Urostomy bag,Assura Urostomy Pouch,Brava belt,Brava Belt for SenSura Mio,Brava Elastic Tape,Brava Elastic Tape Belt,Brava Elastic Tape Straight,Brava Lubricating Deodorant,Brava Mouldable Rings,Brava Paste,Brava Powder,Brava Protective Seal,Brava Protective Seal Convex,Brava Skin Cleanser,Brava Strip… |
|---|---|
| Owner/operator | Coloplast Corp. |
| Owner/operator number | 8010144 |
| Product codes | EXB |
| Device names | EXB - Collector, Ostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | COLOPLAST A/S, Coloplast A/S - Mordrup Site, COLOPLAST (CHINA) LTD., Coloplast Costa Rica SA, Coloplast Hungary, KFT, COLOPLAST HUNGARY KFT, Coloplast Manufacturing US, LLC. |
| Establishment registrations | 9610694, 3003814961, 3005945907, 3008262278, 3011307048, 3015131144, 3030087693 |
| FEI numbers | 3002806731, 3003814961, 3005945907, 3008262278, 3011307048, 3015131144, 3030087693 |
| Establishment operations | Manufacturer, Repackager/Relabeler, 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