Bioserenity SAS
FranceFDA applicant, unverified
- Devices
- 4
What Bioserenity SAS makes
Bioserenity Sas manufactures Neuronaute, a device for neuromodulation targeting neurological conditions, and CARDIOSKIN, a wearable patch designed for cardiac monitoring and rhythm analysis.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II medical devices. Devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Neuronaute Plus Ref K231366
Regimes: 510(k) Registry: 510(k)Neuronaute Ref K202334
Regimes: 510(k) Registry: 510(k)Neuronaute with IceCap 2 & IceCap 2 Small Ref K223644
Regimes: 510(k) Registry: 510(k)Cardioskin Ref K173248
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bioserenity Sas have in the registry?
The registry currently lists 4 devices for Bioserenity Sas. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioserenity Sas's devices?
Among its 4 most recently registered devices, Bioserenity Sas has devices listed in FDA 510(k) (4 devices).
What risk classes do Bioserenity Sas's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Bioserenity Sas's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioserenity Sas in the registry?
The most recently registered devices listed for Bioserenity Sas include Neuronaute Plus, Neuronaute, Neuronaute with IceCap 2 & IceCap 2 Small and CARDIOSKIN.