Dimar S.p.A.
ItalyFDA applicant, unverified
- Devices
- 1
What Dimar S.p.A. makes
Dimar S.P.A. manufactures a range of DMAX non-invasive ventilation (NIV) masks designed for respiratory support, including various models tailored for patient comfort and therapeutic efficacy.
The company’s portfolio is regulated under FDA’s Class II device classification, with devices listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Family of DIMAR DMAX NIV masks Ref K232836
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dimar S.P.A. have in the registry?
The registry currently lists 1 device for Dimar S.P.A.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dimar S.P.A.'s devices?
Among its 1 most recently registered device, Dimar S.P.A. has devices listed in FDA 510(k) (1 device).
What risk classes do Dimar S.P.A.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dimar S.P.A.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dimar S.P.A. in the registry?
The most recently registered devices listed for Dimar S.P.A. include Family of DIMAR DMAX NIV masks.