Iris USA
United Statesfrom the FDA registration address FDA FEI 3002813051
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Iris USA makes
Iris USA manufactures surgical face masks, including the EFMDS-L50Pn BLU model, designed for medical and procedural use to provide barrier protection during surgery.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
Surgical Face Masks, Model: EFMDS-L50Pn BLU Ref K230380
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002813051
- Address
- 11111 80th Ave, Pleasant Prairie, WI, 53158
Frequently asked questions
How many devices does Iris USA have in the registry?
The registry currently lists 1 device for Iris USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Iris USA's devices?
Among its 1 most recently registered device, Iris USA has devices listed in FDA 510(k) (1 device).
What risk classes do Iris USA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Iris USA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Iris USA in the registry?
The most recently registered devices listed for Iris USA include Surgical Face Masks, Model: EFMDS-L50Pn BLU.