Respinnovation
Active in EUDAMEDFrancefrom SRN EUDAMED FDA SRN FR-MF-000010983
- Devices
- 1
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Respinnovation makes
RespInnovation manufactures the RespIn 11, a respiratory device designed for use in medical settings to assist patients with breathing support. This product is intended for controlled ventilation and oxygen therapy, providing precise airflow and pressure regulation for clinical applications.
The RespIn 11 is classified as a Class IIa medical device under EU regulations and is registered in the EUDAMED database. The company is based in France, adhering to European Union regulatory standards for medical devices.
Catalogue
RespIn 11 Ref EMA11010001
Regimes: CE MDD Registry: EUDAMEDGUDID
Company details
- EUDAMED SRN
- FR-MF-000010983
- DUNS number
- 262605672
- EU VAT number
- FR87528273568
- EUDAMED status
- Active
- EUDAMED registered name
- RespInnovation
- EUDAMED abbreviated name
- RI
- Registered address
- 1300, Route des Crêtes, 06560, VALBONNE, France
- Website
- www.respinnovation.com
- [email protected]
- Phone
- +33 9 51 85 68 42
- PRRC contact
- Brent GLOVER
FDA establishments
- Respinnovation Sas US
Frequently asked questions
How many devices does RESPINNOVATION have in the registry?
The registry currently lists 1 device for RESPINNOVATION. Devices recorded under merged duplicate company entries are counted once.
Which registries list RESPINNOVATION's devices?
Among its 1 most recently registered device, RESPINNOVATION has devices listed in EUDAMED (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do RESPINNOVATION's devices fall under?
Among its 1 most recently registered device, the classes recorded for RESPINNOVATION's devices are Class IIa. Each device page shows its own class and authorisation.
What are the newest devices from RESPINNOVATION in the registry?
The most recently registered devices listed for RESPINNOVATION include RespIn 11.
Which FDA establishments are linked to RESPINNOVATION?
1 FDA establishment is linked to RESPINNOVATION in the registry; they are listed on the company page.