Data / Medical devices / Germany / Bee Medic GMBH
Bee Medic GMBH: FDA-registered device maker in Bamberg Bavaria, Germany, 3 510(k) clearances
Bee Medic GMBH is registered with the FDA (registration 3038189172) in Bamberg Bavaria, Germany. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 30, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038189172
- Address
- Kirschaeckerstr. 25, Bamberg Bavaria, Germany, 96052
- Owner or operator
- BEE Medic GmbH (10093168)
- Roles
- Manufacturer
- First device listed
- April 10, 2025
- Registered through
- 2026
- Brand names listed
- BEE Lab, BEE Suite Software, Brummi, Combination Sensor, Cygnet, EEG NeuroAmp, EEG NeuroAmp II, EEG NeuroAmp II.5s and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Biofeedback | HCC | 2 | Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Manufacturer | accessdata.fda.gov |
| Normalizing Quantitative Electroencephalograph Software | OLU | 2 | Manufacturer | accessdata.fda.gov |
| Standard Polysomnograph With Electroencephalograph | OLV | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Auditory, Evoked Response | GWJ | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Photic, Evoked Response | GWE | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 30, 2020 | K193159 | NeuroAmp II, NeuroAmp II.5s | GWQ | Substantially Equivalent | Corscience GmbH & Co. KG | accessdata.fda.gov |
| March 9, 2012 | K112077 | HBIDB - HUMAN BRIAN INDEX SOFTWARE | OLU | Substantially Equivalent | Corscience GmbH & Co. KG | accessdata.fda.gov |
| February 28, 2008 | K073557 | EEG NEUROAMP, MODEL CS10137 | HCC | Substantially Equivalent | Corscience GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Standard Polysomnograph With Electroencephalograph
- All makers of Stimulator, Auditory, Evoked Response
- All makers of Full-Montage Standard Electroencephalograph
- All makers of Stimulator, Photic, Evoked Response
- All makers of Device, Biofeedback
- All makers of Normalizing Quantitative Electroencephalograph Software
Updated December 30, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.