FDA device listing
BEE Lab,BEE Suite Software,Brummi,Combination Sensor,Cygnet,EEG NeuroAmp II,EEG NeuroAmp II.5s,ERPrec,ERP Sync,NeuroAmp…
FDA device listing 1630165187 · BEE Medic GmbH
Key facts
| Proprietary names | BEE Lab,BEE Suite Software,Brummi,Combination Sensor,Cygnet,EEG NeuroAmp II,EEG NeuroAmp II.5s,ERPrec,ERP Sync,NeuroAmp II,NeuroAmp II.5s,NeuroAmp x23,NeuroAmp x39 |
|---|---|
| Owner/operator | BEE Medic GmbH |
| Owner/operator number | 10093168 |
| Premarket submissions | K193159 |
| Product codes | GWE, GWJ, GWQ, HCC, OLV |
| Device names | GWE - Stimulator, Photic, Evoked Response, GWJ - Stimulator, Auditory, Evoked Response, GWQ - Full-Montage Standard Electroencephalograph, HCC - Device, Biofeedback, OLV - Standard Polysomnograph With Electroencephalograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 882.1400, 882.1890, 882.1900, 882.5050 |
| Review panels | Neurology |
| Registered establishments | BEE MEDIC GMBH |
| Establishment registrations | 3038189172 |
| FEI numbers | 3038189172 |
| Establishment operations | Manufacturer |
| 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