FDA device listing
URINARY DRAINAGE BAGS
FDA device listing 1012860967 · SUZHOU HENGXIANG IMP. & EXP. CO., LTD
Key facts
| Proprietary names | URINARY DRAINAGE BAGS |
|---|---|
| Owner/operator | SUZHOU HENGXIANG IMP. & EXP. CO., LTD |
| Owner/operator number | 9010435 |
| Product codes | KNX |
| Device names | KNX - Collector, Urine, (And Accessories) For Indwelling Catheter |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | SUZHOU HENGXIANG IMP. & EXP. CO., LTD |
| Establishment registrations | 9680934 |
| FEI numbers | 3006993165 |
| Establishment operations | Foreign Exporter |
| 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