BEE Medic GmbH
Germany DE-MF-000034511 Last updated 23 Oct 2026
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- Devices
- 8
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
ERPrec Ref A001127
NeuroAmp x39 Ref A001008
pIRx3 Ref A001004
NeuroAmp x23 Ref A001007
NeuroAmp II.5s Ref A001001
NeuroAmp II Ref A001000
Combination Sensor Ref A001003
Brummi Ref A01005
EUDAMED certificates
TÜV SÜD Product Service GmbH 0123 1 certificate
- G15 134578 0002 Issued
Quality management system EU MDR
- Issued
- 28 Sep 2026
- Expires
- 27 Sep 2031
Related companies
Notified bodies
What BEE Medic GmbH makes
BEE Medic GmbH manufactures portable and modular neurophysiological monitoring devices, including the NeuroAmp series (x39, x23, II.5s, and II) for EEG and evoked potential recordings, as well as the pIRx3 for photoplethysmography and the Combination Sensor for multimodal signal acquisition. The Brummi is a wearable device designed for continuous monitoring of physiological parameters in clinical and research settings.
The company’s products are classified under EU Medical Device Regulation as Class I devices and are registered in the EU’s eudamed database. The portfolio is primarily intended for use within the European Union, adhering to applicable regulatory requirements for non-invasive diagnostic and monitoring devices.
Frequently asked questions
What types of medical devices does BEE Medic GmbH manufacture?
BEE Medic GmbH specializes in portable and modular neurophysiological monitoring devices. Their product line includes EEG and evoked potential recording systems like the NeuroAmp series (x39, x23, II.5s, and II), a photoplethysmography device called the pIRx3, and a multimodal Combination Sensor for simultaneous signal acquisition. Additionally, they offer the Brummi, a wearable device for continuous monitoring of physiological parameters in clinical and research environments.
Where is BEE Medic GmbH based, and where are their devices primarily used?
BEE Medic GmbH is based in Germany (DE). Their devices are primarily designed for use within the European Union, where they must comply with the applicable regulatory requirements for non-invasive diagnostic and monitoring tools.
Which regulatory registries list BEE Medic GmbH’s devices?
BEE Medic GmbH’s devices are registered in the EU’s eudamed database, which is the official registry for medical devices under the EU Medical Device Regulation. This ensures transparency and traceability of their products within the European market.
How are BEE Medic GmbH’s devices classified under EU regulations?
BEE Medic GmbH’s devices are classified as Class I under the EU Medical Device Regulation. This classification applies to low-risk devices, such as non-invasive monitoring and diagnostic tools, which typically require fewer regulatory controls compared to higher-risk categories.
Information
- Country
- Germany
- Address
- 25, Kirschäckerstr., Bamberg, Germany
- Website
- www.beemedic.com
- [email protected]
- Phone
- +49 7731 96969-0
- PRRC contact
- Johannes Spallek
- EUDAMED SRN
- DE-MF-000034511
- FDA FEI number
- 3038189172