FDA device listing
VitreJect® Ophthalmic Syringes,VitreJect® Syringe
FDA device listing 1953605694 · SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD.
Key facts
| Proprietary names | VitreJect® Ophthalmic Syringes,VitreJect® Syringe |
|---|---|
| Owner/operator | SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. |
| Owner/operator number | 9078499 |
| Product codes | FMF, QLY, QNQ |
| Device names | FMF - Syringe, Piston, QLY - Ophthalmic Syringe, QNQ - Low Dead Space Piston Syringe |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5860 |
| Review panels | General Hospital |
| Registered establishments | SHANGHAI KINDLY ENTERPRISE DEVELOPMENT GROUP CO., LTD. |
| Establishment registrations | 3005405146 |
| FEI numbers | 3005405146 |
| Establishment operations | Contract Manufacturer, 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