Medtech S.A.S.
FranceFDA applicant, unverified
- Devices
- 3
What Medtech S.A.S. makes
Medtech S.A.S manufactures ROSA surgical devices, including the ROSA ONE Brain Application, designed for neurosurgical procedures. These systems are intended for precise, image-guided interventions in brain surgery.
The company’s portfolio is regulated under FDA Class II devices, with products listed via the 510(k) clearance pathway. Medtech S.A.S operates from the United States.
Catalogue
Rosa Surgical Device Ref K101791
Regimes: 510(k) Registry: 510(k)ROSA ONE Brain Application Ref K231103
Regimes: 510(k) Registry: 510(k)ROSA ONE Brain application Ref K214065
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Medtech S.A.S have in the registry?
The registry currently lists 3 devices for Medtech S.A.S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medtech S.A.S's devices?
Among its 3 most recently registered devices, Medtech S.A.S has devices listed in FDA 510(k) (3 devices).
What risk classes do Medtech S.A.S's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Medtech S.A.S's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medtech S.A.S in the registry?
The most recently registered devices listed for Medtech S.A.S include ROSA SURGICAL DEVICE and ROSA ONE Brain Application.