Vivalyx GmbH
Active in EUDAMEDGermanyfrom SRN EUDAMED SRN DE-MF-000045202
- Devices
- 1
- Registrations
- EUDAMED
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
Catalogue
Omnisol Ref OMN-1000
CE MDR EUDAMED
Company details
- EUDAMED SRN
- DE-MF-000045202
- EU VAT number
- DE356748496
- EUDAMED status
- Active
- EUDAMED registered name
- Vivalyx GmbH
- EUDAMED abbreviated name
- Vivalyx
- Registered address
- 60-62, Gottfried-Hagen-Straße, 51105, Köln, Germany
- Website
- vivalyx.com/
- [email protected]
- Phone
- +49 (0)221 980 923 99
- PRRC contact
- Efrain Salinas Hernandez
EUDAMED certificates
2 certificates2 valid, 0 expiredMDR 2next expiry 17 Aug 2031
Notified body 2797 2 certificates
- MDR 809921 Issued
Quality management system EU MDR
- Issued
- 18 Aug 2026
- Expires
- 17 Aug 2031
- MDR 809923 Issued
Technical documentation EU MDR
- Issued
- 18 Aug 2026
- Expires
- 17 Aug 2031
From the company website
Cologne / Aachen – August 25, 2026 – Vivalyx, an organ vitality tech company developing the next generation of organ preservation solutions, has been formally
Frequently asked questions
How many devices does Vivalyx GmbH have in the registry?
The registry currently lists 1 device for Vivalyx GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vivalyx GmbH's devices?
Among its 1 most recently registered device, Vivalyx GmbH has devices listed in EUDAMED (1 device).
What risk classes do Vivalyx GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Vivalyx GmbH's devices are Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Vivalyx GmbH?
EUDAMED lists 2 certificates for Vivalyx GmbH (quality management system; technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 2026-08-18.
What are the newest devices from Vivalyx GmbH in the registry?
The most recently registered devices listed for Vivalyx GmbH include Omnisol.