BiOSENCY
Inactive in EUDAMED since 2026Francefrom SRN EUDAMED SRN FR-MF-000007771
Inactive. This company's EUDAMED actor record is marked inactive. Check the current status before ordering.
- Devices
- 8
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What BiOSENCY makes
BiOSENCY manufactures telemonitoring devices and software for respiratory health management, including wearable sensors like the Bora Band and patient-focused systems such as Bora Connect for Home. These solutions enable remote tracking of patient vitals and predictive alerts for exacerbations, alongside study-specific configurations like Bora Connect for Study eMeuse and Bora Connect for Study Boreal. The portfolio also includes firmware for network gateway devices and software development kits for Android integration.
The company’s devices fall under EU Class IIa classification and are registered in the EUDAMED database. BiOSENCY is based in France, adhering to regulatory requirements for medical device compliance within the European Union.
Catalogue
Bora Connect for Home Ref BX-100_AAA
Regimes: CE MDR, withdrawn Registry: EUDAMEDBORA Native Android Gateway Software Development Kit Ref BP-100_AA0
Regimes: CE MDR, withdrawn Registry: EUDAMEDBora Band Ref BB-100_A00
Regimes: CE MDR, withdrawn Registry: EUDAMEDBora Connect for Study eMeuse Ref BX-100_AAB
Regimes: CE MDR, withdrawn Registry: EUDAMEDBC4H-Exa-Ic Ref BX-100_AAE
Regimes: CE MDR, withdrawn Registry: EUDAMEDBora Connect for Study Boreal Ref BX-100_AAC
Regimes: CE MDR, withdrawn Registry: EUDAMEDNetwork Gateway device Firmware Ref SGW-092-1_AA0
Regimes: CE MDR, withdrawn Registry: EUDAMEDBORA CONNECT patient Ref KS-100_A00
Regimes: CE MDR, withdrawn Registry: EUDAMED
Company details
- EUDAMED SRN
- FR-MF-000007771
- EU VAT number
- FR66830861860
- EUDAMED status
- Inactive since 2026
- EUDAMED registered name
- BiOSENCY
- Registered address
- 13, Rue Claude Chappe, 35510, Cesson Sévigné, France
- Website
- biosency.com/
- [email protected]
- Phone
- +33 (0)2 21 65 70 01
- PRRC contact
- Alexis Toullec
From the company website
Our home-based telemonitoring solution for patients with respiratory impairment predicts exacerbations and tracks their health.
Frequently asked questions
How many devices does BiOSENCY have in the registry?
The registry currently lists 8 devices for BiOSENCY. Devices recorded under merged duplicate company entries are counted once.
Which registries list BiOSENCY's devices?
Among its 8 most recently registered devices, BiOSENCY has devices listed in EUDAMED (8 devices).
What risk classes do BiOSENCY's devices fall under?
Among its 8 most recently registered devices, the classes recorded for BiOSENCY's devices are Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from BiOSENCY in the registry?
The most recently registered devices listed for BiOSENCY include Bora Connect for Home, BORA Native Android Gateway Software Development Kit, Bora Band and Bora Connect for Study eMeuse.