FDA device listing
Leg bag,Speci-Cath kit,Urine Drainage Bag
FDA device listing 1205536906 · ChangShu Rozer Sterilization Technology Co., Ltd.
Key facts
| Proprietary names | Leg bag,Speci-Cath kit,Urine Drainage Bag |
|---|---|
| Owner/operator | ChangShu Rozer Sterilization Technology Co., Ltd. |
| Owner/operator number | 10049312 |
| Product codes | EYZ |
| Device names | EYZ - System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Device class | Class I |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CHANGSHU ROZER STERILIZATION TECHNOLOGY CO., LTD. |
| Establishment registrations | 3011707784 |
| FEI numbers | 3011707784 |
| Establishment operations | Contract Sterilizer |
| 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