Therapixel SA
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000035499
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
MammoScreen® (5) Ref K260714
Regimes: 510(k) Registry: 510(k)MammoScreen Ref MAML
Regimes: CE MDD 510(k) Registry: EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000035499
- EU VAT number
- FR04793920521
- EUDAMED status
- Active
- EUDAMED registered name
- THERAPIXEL SA
- Registered address
- 455, PROMENADE DES ANGLAIS, 06200, NICE, France
- Website
- www.therapixel.com
- linkedin.com/company/therapixel
- facebook.com/therapixel
- [email protected]
- Phone
- +33972552039
- PRRC contact
- Shalyna Long Bansropun
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 7 Jul 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 829839 Active
Quality management system EU MDR
- Issued
- 8 Jul 2026
- Expires
- 7 Jul 2031
From the company website
Therapixel is one of the leading French software companies specializing in artificial intelligence applied to medical imaging.
Frequently asked questions
How many devices does THERAPIXEL SA have in the registry?
The registry currently lists 2 devices for THERAPIXEL SA. Devices recorded under merged duplicate company entries are counted once.
Which registries list THERAPIXEL SA's devices?
Among its 2 most recently registered devices, THERAPIXEL SA has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do THERAPIXEL SA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for THERAPIXEL SA's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for THERAPIXEL SA?
EUDAMED lists 1 certificate for THERAPIXEL SA (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 8 Jul 2026.
What are the newest devices from THERAPIXEL SA in the registry?
The most recently registered devices listed for THERAPIXEL SA include MammoScreen® (5) and MammoScreen.