Swiss Bionic Solutions Schweiz GmbH
Active in EUDAMEDSwitzerlandfrom SRN EUDAMED SRN CH-MF-000034313
- Devices
- 6
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Swiss Bionic Solutions Schweiz GmbH makes
Swiss Bionic Solutions manufactures pulsed electromagnetic field (PEMF) therapy devices, including hybrid systems like the iMRS prime and standalone units such as the Omnium1 Intelligent Wellness. Their portfolio also includes brain stimulation devices like the OmniBrain and Exagon Brain, as well as wearable sensors like the Exagon Sense for monitoring physiological signals.
All listed devices fall under EU Class IIa classification and are registered in the EU’s eudamed database. The company is based in Switzerland and adheres to relevant European medical device regulations for these categories.
Catalogue
Omnium1 Intelligent Wellness Ref 75210
Regimes: CE MDR, withdrawn Registry: EUDAMEDiMRS prime Hybrid Ref 80004
Regimes: CE MDR, withdrawn Registry: EUDAMEDiMRS prime Ref 80001
Regimes: CE MDR, withdrawn Registry: EUDAMEDOmniBrain Ref 70121
Regimes: CE MDR, withdrawn Registry: EUDAMEDExagon Brain Ref 80027
Regimes: CE MDR, withdrawn Registry: EUDAMEDExagon Sense Ref 80029
Regimes: CE MDR, withdrawn Registry: EUDAMED
Company details
- EUDAMED SRN
- CH-MF-000034313
- SRN (system / procedure pack)
- CH-PR-000034867
- EU VAT number
- CHE-116.380.708
- EUDAMED status
- Active
- EUDAMED registered name
- Swiss Bionic Solutions Schweiz GmbH
- Address
- Firststrasse 6, 8835 Feusisberg, Switzerland
- Website
- www.swissbionic.com
- [email protected]
- Phone
- +41622955951
- PRRC contact
- Wolfgang Jaksch
From the company website
Swiss Bionic Solutions - Certified Medical PEMF Devices for Clinical and Home Use | iMRS prime & Omnium1 | SWISS Engineering! - GERMAN Technology!
Frequently asked questions
How many devices does Swiss Bionic Solutions Schweiz GmbH have in the registry?
The registry currently lists 6 devices for Swiss Bionic Solutions Schweiz GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Swiss Bionic Solutions Schweiz GmbH's devices?
Among its 6 most recently registered devices, Swiss Bionic Solutions Schweiz GmbH has devices listed in EUDAMED (6 devices).
What risk classes do Swiss Bionic Solutions Schweiz GmbH's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Swiss Bionic Solutions Schweiz GmbH's devices are Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from Swiss Bionic Solutions Schweiz GmbH in the registry?
The most recently registered devices listed for Swiss Bionic Solutions Schweiz GmbH include Omnium1 Intelligent Wellness, iMRS prime Hybrid, iMRS prime and OmniBrain.