FDA device listing
Alpha starter kit,Madsen Accuscreen/Alpha,Small tip kit,Type 1077 - MADSEN Aipha OAE+,Type 1077 - MADSEN Alpha OAE
FDA device listing 1449752607 · Natus Medical Denmark ApS
Key facts
| Proprietary names | Alpha starter kit,Madsen Accuscreen/Alpha,Small tip kit,Type 1077 - MADSEN Aipha OAE+,Type 1077 - MADSEN Alpha OAE |
|---|---|
| Owner/operator | Natus Medical Denmark ApS |
| Owner/operator number | 10093195 |
| Premarket submissions | K132957 |
| 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 | Natus Medical Denmark ApS, Natus Sensory Ireland Ltd |
| Establishment registrations | 9612197, 3034880867 |
| FEI numbers | 3002807554, 3034880867 |
| Establishment operations | Complaint File Establishment, Manufacturer, Specification Developer, Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 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