Flaem Nuova S.P.A.
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Flaem Nuova S.P.A. makes
Flaem Nuova S.P.A. manufactures nebulizer devices, including families such as Master Neb, Primo Neb, SC03, Neb Aid, 4.2.NEB, Q03, FJ03, and Walkie-Neb, as well as the Flaem Nuova RF6 Basic and RF6 Plus nebulizers.
These devices are classified as Class II medical devices and are listed in the FDA 510(k) registry; the company is based in the United States.
Catalogue
- 510(k) 510(k)
Flaem Nuova RF6 Basic And RF6 Plus Nebulizers Ref K062484
510(k) 510(k)
FDA establishments
- Flaem Nuova S.P.A. Desenzano del Garda Brescia · IT FEI 1000337819
Frequently asked questions
How many devices does Flaem Nuova S.P.A. have in the registry?
The registry currently lists 2 devices for Flaem Nuova S.P.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Flaem Nuova S.P.A.'s devices?
Among its 2 most recently registered devices, Flaem Nuova S.P.A. has devices listed in FDA 510(k) (2 devices).
What risk classes do Flaem Nuova S.P.A.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Flaem Nuova S.P.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Flaem Nuova S.P.A. in the registry?
The most recently registered devices listed for Flaem Nuova S.P.A. include FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB and FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS.
Which FDA establishments are linked to Flaem Nuova S.P.A.?
1 FDA establishment is linked to Flaem Nuova S.P.A. in the registry; they are listed on the company page.