FDA device listing
Bulb Syringe,Enteral irrigation flat top syringe,Enteral irrigation ring top syringe,Enteral irrigation thumb control…
FDA device listing 1708645394 · SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
Key facts
| Proprietary names | Bulb Syringe,Enteral irrigation flat top syringe,Enteral irrigation ring top syringe,Enteral irrigation thumb control syringe w/500ml graduate,Irrigation flat top syringe,Irrigation tray w/thumb control syringe,Oral Caretip Sterile Syringe,Oral Dispenser,Oral Dispensing Syringe,Oral Syringe,SOL-M Oral Dispensing Syringe |
|---|---|
| Owner/operator | SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. |
| Owner/operator number | 9078499 |
| Product codes | KYX |
| Device names | KYX - Dispenser, Liquid Medication |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6430 |
| Review panels | General Hospital |
| Registered establishments | SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. |
| Establishment registrations | 3005405146 |
| FEI numbers | 3005405146 |
| Establishment operations | Contract Manufacturer, 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