FDA device listing
Ostomy Bag, Ostomy Barrier, Ostomy Barrier Rings,Ostomy Strip, Ostomy Belt, Ostomy Paste, Ostomy Skin Protective…
FDA device listing 1359455547 · Ningbo Risenmed Technology Co.,Ltd.
Key facts
| Proprietary names | Ostomy Bag, Ostomy Barrier, Ostomy Barrier Rings,Ostomy Strip, Ostomy Belt, Ostomy Paste, Ostomy Skin Protective Power,Urinary Drainage Bag |
|---|---|
| Owner/operator | Ningbo Risenmed Technology Co.,Ltd. |
| Owner/operator number | 10085370 |
| Product codes | FON |
| Device names | FON - Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | NINGBO RISENMED TECHNOLOGY CO.,LTD. |
| Establishment registrations | 3023339256 |
| FEI numbers | 3023339256 |
| Establishment operations | 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