FDA device listing
MB 11 with BERAPhone Probe
FDA device listing 1673398325 · DEMANT A/S
Key facts
| Proprietary names | MB 11 with BERAPhone Probe |
|---|---|
| Owner/operator | DEMANT A/S |
| Owner/operator number | 8010048 |
| Premarket submissions | K082035 |
| Product codes | GWJ |
| Device names | GWJ - Stimulator, Auditory, Evoked Response |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1900 |
| Review panels | Neurology |
| Registered establishments | DGS Diagnostics Sp. z o.o, DIAGNOSTIC GROUP LLC, INTERACOUSTICS A/S, MAICO Diagnostics GmbH |
| Establishment registrations | 2113281, 9710051, 3002504821, 3011310592 |
| FEI numbers | 2113281, 3000254565, 3002504821, 3011310592 |
| Establishment operations | Complaint File Establishment, Contract Manufacturer, Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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