Customfab, Inc.
Country not established FDA FEI 3001236830
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Customfab, Inc. makes
Customfab, Inc. manufactures surgical masks, which are designed for single-use in clinical and procedural settings to protect healthcare workers and patients from airborne contaminants.
The company’s surgical masks are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The products are intended for use in the United States.
Catalogue
Surgical Mask Ref K203012
510(k) 510(k)
Company details
- FDA FEI number
- 3001236830
- Address
- 353 N Euclid Way, Anaheim, CA, 92801
Frequently asked questions
How many devices does Customfab, Inc. have in the registry?
The registry currently lists 1 device for Customfab, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Customfab, Inc.'s devices?
Among its 1 most recently registered device, Customfab, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Customfab, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Customfab, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Customfab, Inc. in the registry?
The most recently registered devices listed for Customfab, Inc. include Surgical Mask.