FDA device listing
Ostomy Cream, Skin Barrier Strip, Ostomy Fastened Ring
FDA device listing 1388534855 · Hubei Hendry Medical Appliance Co., Ltd
Key facts
| Proprietary names | Ostomy Cream, Skin Barrier Strip, Ostomy Fastened Ring |
|---|---|
| Owner/operator | Hubei Hendry Medical Appliance Co., Ltd |
| Owner/operator number | 10084670 |
| Product codes | EZR |
| Device names | EZR - Cement, Stomal Appliance, Ostomy |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5900 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | HUBEI HENDRY MEDICAL APPLIANCE CO., LTD |
| Establishment registrations | 3013863160 |
| FEI numbers | 3013863160 |
| Establishment operations | Foreign Exporter, 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