FDA device listing
Active Pro IX,CROS,CROS AX,Insio,Insio Charge&Go,Insio IX,Intuis,Intuis 3,Intuis 4,Motion Charge&Go,Pure…
FDA device listing 1664460054 · WSAUD A/S
Key facts
| Proprietary names | Active Pro IX,CROS,CROS AX,Insio,Insio Charge&Go,Insio IX,Intuis,Intuis 3,Intuis 4,Motion Charge&Go,Pure Charge&Go,Signia Motion,Signia Pure,Silk Charge&Go,Styletto,Styletto AX |
|---|---|
| Owner/operator | WSAUD A/S |
| Owner/operator number | 10023518 |
| Premarket submissions | K011366 |
| Product codes | KLW |
| Device names | KLW - Masker, Tinnitus |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3400 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Sivantos GmbH |
| Establishment registrations | 3005019184 |
| FEI numbers | 3005019184 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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