FDA device listing
REXEED SERIES DIALYZERS
FDA device listing 1657161878 · KOGA ISOTOPE LTD.
Key facts
| Proprietary names | REXEED SERIES DIALYZERS |
|---|---|
| Owner/operator | KOGA ISOTOPE LTD. |
| Owner/operator number | 10025197 |
| Product codes | KDI, MSF |
| Device names | KDI - Dialyzer, High Permeability With Or Without Sealed Dialysate System, MSF - Hemodialyzer, Re-Use, High Flux |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5860 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | KOGA ISOTOPE LTD. |
| Establishment registrations | 3002807408 |
| FEI numbers | 3002807408 |
| Establishment operations | 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