Cardiawave SA
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000000680
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
Interface-Membrane Ref CW-IM-001A
CE MDR EUDAMEDValvosoft® Ref CW-VS-002A
CE MDR EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000000680
- EU VAT number
- FR 35 805 240 108
- EUDAMED status
- Active
- EUDAMED registered name
- CARDIAWAVE SA
- Registered address
- 3-5, rue Jules Guesde, 92300, Levallois-Perret, France
- Website
- www.cardiawave.com
- [email protected]
- Phone
- +33 1 5526 8216
- PRRC contact
- Clémence PUPIER
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Nov 2030
Notified body 0344 1 certificate
- 2286829CE01 Issued
Quality management system EU MDR
- Issued
- 26 Nov 2025
- Expires
- 1 Nov 2030
From the company website
To treat calcific aortic stenosis, Cardiawave has developed a Non-Invasive Ultrasound Therapy (NIUT). NIUT consists in softening the aortic valve, not replacing it. No surgery is required. Our unique approach could represent both an alternative for patients non eligible for SAVR/TAVR (Surgical Aortic Valve Replacement) and a complementary approach to current procedures to prepare overly calcified aortic valves before the deployment of a TAVR.
Frequently asked questions
How many devices does CARDIAWAVE SA have in the registry?
The registry currently lists 2 devices for CARDIAWAVE SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list CARDIAWAVE SA's devices?
Among its 2 most recently registered devices, CARDIAWAVE SA has devices listed in EUDAMED (2 devices).
What risk classes do CARDIAWAVE SA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for CARDIAWAVE SA's devices are Class IIb. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for CARDIAWAVE SA?
EUDAMED lists 1 certificate for CARDIAWAVE SA (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-11-26.
What are the newest devices from CARDIAWAVE SA in the registry?
The most recently registered devices listed for CARDIAWAVE SA include Interface-Membrane and Valvosoft®.