Dr. Berndsen GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000005561
- Devices
- 31
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Dr. Berndsen GmbH makes
Dr. Berndsen GmbH manufactures a series of non-invasive orofacial therapy devices called FaceFormer, including variants such as FaceFormer ZERO and FaceFormer ONE (available in clear and blue). These devices are designed to target the coordinated function of breathing, swallowing, and orofacial muscles through structured therapy exercises.
The FaceFormer portfolio is classified under EU Medical Device Regulation as Class I and is registered in the EUDAMED database. The company is based in Germany and adheres to EU regulatory requirements for non-invasive, low-risk devices.
Catalogue
Search and filter all 31 devicesCompany details
- EUDAMED SRN
- DE-MF-000005561
- EU VAT number
- DE813420652
- EUDAMED status
- Active
- EUDAMED registered name
- Dr. Berndsen GmbH
- EUDAMED abbreviated name
- Dr. Berndsen
- Registered address
- 25, Wasserstr., 59423, Unna, Germany
- Website
- drberndsen.de
- [email protected]
- Phone
- +49230389991
- PRRC contact
- Klaus Jürgen Berndsen
From the company website
Official shop of the manufacturer: FaceFormer ZERO and ONE, sets for adults and children, webinars and accessories. From 15 € shipping free, shipping to 43 countries.
Frequently asked questions
How many devices does Dr. Berndsen GmbH have in the registry?
The registry currently lists 31 devices for Dr. Berndsen GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dr. Berndsen GmbH's devices?
Among its 31 most recently registered devices, Dr. Berndsen GmbH has devices listed in EUDAMED (31 devices).
What risk classes do Dr. Berndsen GmbH's devices fall under?
Among its 31 most recently registered devices, the classes recorded for Dr. Berndsen GmbH's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dr. Berndsen GmbH in the registry?
The most recently registered devices listed for Dr. Berndsen GmbH include FaceFormer ZERO, FaceFormer ONE clear, FaceFormer ONE blue and FaceFormer ZERO plus ONE.