Diabeloop
Active in EUDAMEDFrancefrom SRN EUDAMED SRN FR-MF-000007564
Part of Diabeloop SA
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
What Diabeloop makes
Diabeloop develops an automated insulin delivery system, including the DBLG2 device, which integrates continuous glucose monitoring and insulin pump technology to assist in managing type 1 diabetes.
The company’s portfolio is regulated under FDA’s Class II device classification, with products authorised via the 510(k) pathway. The company is based in the United States.
Catalogue
Company details
- EUDAMED SRN
- FR-MF-000007564
- EU VAT number
- FR04810416438
- EUDAMED status
- Active
- EUDAMED registered name
- DIABELOOP SA
- Registered address
- 17, rue Félix Esclangon, 38000, Grenoble, France
- Website
- www.diabeloop.fr
- [email protected]
- PRRC contact
- Erik HUNEKER
Frequently asked questions
How many devices does Diabeloop have in the registry?
The registry currently lists 2 devices for Diabeloop. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diabeloop's devices?
Among its 2 most recently registered devices, Diabeloop 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 Diabeloop's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Diabeloop's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diabeloop in the registry?
The most recently registered devices listed for Diabeloop include DBLG2 and YourLoops.