Rebrain, SAS
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000006824
Rebrain, SAS is a medical device manufacturer based in France, with 3 devices listed in FDA 510(k), FDA GUDID and EUDAMED (FDA Class II) as of 13 Nov 2026.
- Devices
- 3
- Registrations
- EUDAMED
Registry facts
- Registries
- FDA 510(k) 2
- FDA GUDID 2
- EUDAMED 1
- Device classes
- FDA Class II 3
- Identifiers
- EUDAMED SRN FR-MF-000006824
At a glance
Market reach
- European Union
- EUDAMED actor
What Rebrain, SAS makes
Rebrain, Sas develops software applications for stereotactic systems, including versions of OptimMRI designed to assist in medical imaging and planning procedures.
The company’s portfolio is regulated under FDA Class II devices, with products listed via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system.
Catalogue
- Regimes: 510(k) Registry: GUDID
OptimMRI Ref K230150
Regimes: CE MDR 510(k) Registry: EUDAMED510(k)GUDIDOptimMRI (v2) Ref K242054
Regimes: CE MDR 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- FR-MF-000006824
- EU VAT number
- FR87892511866
- EUDAMED status
- Active
- EUDAMED registered name
- REBRAIN
- Registered address
- Avenue du Haut Lévêque, PTIB, Hôpital Xavier Arnozan, 33600, Pessac, France
- Website
- rebrain.eu/
- support@rebrain.eu
- Phone
- +33557102858
- PRRC contact
- Thomas QUEUCHE
Frequently asked questions
How many devices does Rebrain, Sas have in the registry?
The registry currently lists 3 devices for Rebrain, Sas. Devices recorded under merged duplicate company entries are counted once.
Which registries list Rebrain, Sas's devices?
Among its 3 most recently registered devices, Rebrain, Sas has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Rebrain, Sas's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Rebrain, Sas's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Rebrain, Sas in the registry?
The most recently registered devices listed for Rebrain, Sas include OptimMRI v1.2.0, OptimMRI and OptimMRI (v2).