FDA device listing
Rex Enterprises Co., Ltd.
FDA device listing 1764383778 · Leda Innovations USA Inc.
Key facts
| Proprietary names | Rex Enterprises Co., Ltd. |
|---|---|
| Owner/operator | Leda Innovations USA Inc. |
| Owner/operator number | 10095686 |
| Product codes | MEF |
| Device names | MEF - Ring, Teething, Non-Fluid Filled |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.5550 |
| Review panels | Dental |
| Registered establishments | Rex Enterprises Co., Ltd. |
| Establishment registrations | 3002857192 |
| FEI numbers | 3002857192 |
| 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