FDA device listing
DIRUI,Dirui H11, Dirui H10, Dirui H8
FDA device listing 1472820956 · DIRUI INDUSTRIAL CO., LTD.
Key facts
| Proprietary names | DIRUI,Dirui H11, Dirui H10, Dirui H8 |
|---|---|
| Owner/operator | DIRUI INDUSTRIAL CO., LTD. |
| Owner/operator number | 9049667 |
| Product codes | JRE |
| Device names | JRE - Refractometer For Clinical Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 862.2800 |
| Review panels | Clinical Chemistry |
| Registered establishments | DIRUI INDUSTRIAL CO., LTD. |
| Establishment registrations | 3003741796 |
| FEI numbers | 3003741796 |
| Establishment operations | 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