FDA device listing
AGXO A,AGXO B,AGXO E,AGXO F,AGXO G S,AudigyFit 2,Bernafon Alpha,Bernafon Alpha XT,Bernafon App,Bernafon AQ,Bernafon…
FDA device listing 1841724562 · DEMANT A/S
Key facts
| Proprietary names | AGXO A,AGXO B,AGXO E,AGXO F,AGXO G S,AudigyFit 2,Bernafon Alpha,Bernafon Alpha XT,Bernafon App,Bernafon AQ,Bernafon Capto,Bernafon Charger MNB R,Bernafon Charger MNB T R,Bernafon Charger MNR,Bernafon Charger Plus MNB R,Bernafon Charger Plus MNB T R,Bernafon Charger Plus MNR,Bernafon Charger Plus MNR T R,Bernafon Charger Plus nxtCIC R,Bernafon Coral,Bernafon CROS II MNR R,Bernafon CROS MNR T… |
|---|---|
| Owner/operator | DEMANT A/S |
| Owner/operator number | 8010048 |
| Premarket submissions | K133308 |
| 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 | Demant Operations Poland Sp. z o.o., Demant Operations, S.a. De C.v., Oticon A/S, OTICON, INC. |
| Establishment registrations | 2240713, 3005465494, 3009307953, 3017441596 |
| FEI numbers | 2240713, 3005465494, 3009307953, 3017441596 |
| Establishment operations | Manufacturer, Repackager/Relabeler, 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