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bruXane GmbH

Active in EUDAMED

Germanyfrom SRN EUDAMED SRN DE-MF-000034881

Devices
3
Registrations
EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor

What bruXane GmbH makes

bruXane GmbH manufactures dental splints designed to address bruxism, including the bruXane Personal, bruXane 2go, and bruXane Ladebox. These devices incorporate biofeedback technology to monitor and reduce grinding activities, track stress-related factors via a Crunch Tracker, and provide feedback through vibrations. The products are intended for use at home to protect teeth and dental implants from wear caused by bruxism.

The company’s dental splints fall under EU Class I medical devices and are registered in the EU’s eudamed database. The portfolio is regulated under EU Medical Device Regulations, ensuring compliance with safety and performance standards for non-invasive dental protection devices. The manufacturer is based in Germany.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

  • bruXane Personal Ref bruXanePersonal3DD

    Class I
    Active CE MDR EUDAMED I

  • bruXane 2go Ref bruXane2goOpti

    Class I
    Active CE MDR EUDAMED I

  • bruXane Ladebox Ref bruXaneLadebox

    Class I
    Active CE MDR EUDAMED I

Company details

EUDAMED SRN
DE-MF-000034881
EU VAT number
DE273638541
EUDAMED status
Active
EUDAMED registered name
bruXane GmbH
Registered address
43, Steinweg, 35037, Marburg, Germany
Phone
+4964219994383(from company website)
PRRC contact
Stefan Bradenbrink(public in EUDAMED)

From the company website

Read 18 Oct 2026

Pre-order here. The optimized bruXane 2go is available from autumn 2026 – small, smart and optimized crunch splint With biofeedback: gentle vibration and summon to protect the teeth and implants Biofeedback to eliminate the sequential symptoms of bruxism Reduces crunch activities on average to 75% Eliminate sequential symptoms of tooth grinding crunch tracker documents your bruxism/stress factors With integrated biofeedback findings vibration [...]

Translated from the manufacturer's own website. Source

Frequently asked questions

How many devices does bruXane GmbH have in the registry?

The registry currently lists 3 devices for bruXane GmbH. Devices recorded under merged duplicate company entries are counted once.

Which registries list bruXane GmbH's devices?

Among its 3 most recently registered devices, bruXane GmbH has devices listed in EUDAMED (3 devices).

What risk classes do bruXane GmbH's devices fall under?

Among its 3 most recently registered devices, the classes recorded for bruXane GmbH's devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from bruXane GmbH in the registry?

The most recently registered devices listed for bruXane GmbH include bruXane Personal, bruXane 2go and bruXane Ladebox.

Generated automatically from registry data and not verified by a human reviewer.