Efofex, Inc.
United StatesFDA applicant, unverified FDA FEI 3042366009
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Efofex, Inc. makes
Efofex, Inc. manufactures disposable surgical masks intended for non-sterile use in medical and clinical settings. These masks are designed to provide barrier protection against airborne particles and splashes during surgical procedures and patient care.
The company’s disposable surgical masks fall under FDA Class II regulation and are listed via the 510(k) pathway. The devices are registered in the U.S. under FDA records.
Catalogue
Disposable Surgical Face Mask Ref K223823
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3042366009
- Address
- 1300 N Dixieland Rd, Rogers, AR, 72756
Frequently asked questions
How many devices does Efofex, Inc. have in the registry?
The registry currently lists 2 devices for Efofex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Efofex, Inc.'s devices?
Among its 2 most recently registered devices, Efofex, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Efofex, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Efofex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Efofex, Inc. in the registry?
The most recently registered devices listed for Efofex, Inc. include Disposable Surgical Face Mask and Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300).