FDA device listing
Kamex International,NEOPRENE WRISTBAND S, M, L,,RIGHT AND LEFT THUMB SPLINT WRISTBAND S/M, L/XL,UNIVERSAL WRIST BRACE…
FDA device listing 1794738673 · Kamex International S.A.S
Key facts
| Proprietary names | Kamex International,NEOPRENE WRISTBAND S, M, L,,RIGHT AND LEFT THUMB SPLINT WRISTBAND S/M, L/XL,UNIVERSAL WRIST BRACE AND PLUS RIGHT AND LEFT,ZIMMERS SPLINT |
|---|---|
| Owner/operator | Kamex International S.A.S |
| Owner/operator number | 10084653 |
| Product codes | ILH |
| Device names | ILH - Splint, Hand, And Components |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | KAMEX INTERNATIONAL S.A.S |
| Establishment registrations | 3022114800 |
| FEI numbers | 3022114800 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Foreign Private Label Distributor, 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