United Sewing Automation, Inc.
Country not established
- Devices
- 2
What United Sewing Automation, Inc. makes
United Sewing Automation, Inc. manufactures single-use, non-antimicrobial surgical and medical face masks, including high fluid-resistant variants designed for surgical, surgical, and procedural applications.
These products are regulated as Class II devices in the US and are listed under FDA’s 510(k) and UDI programs. The company is based in the United States.
Catalogue
- GUDID
- 510(k) 510(k)
Company details
- DUNS number
- 050795583
- [email protected]
- Phone
- 3364154591
Frequently asked questions
How many devices does United Sewing Automation, Inc. have in the registry?
The registry currently lists 2 devices for United Sewing Automation, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list United Sewing Automation, Inc.'s devices?
Among its 2 most recently registered devices, United Sewing Automation, Inc. has devices listed in FDA 510(k) (1 device) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do United Sewing Automation, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for United Sewing Automation, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from United Sewing Automation, Inc. in the registry?
The most recently registered devices listed for United Sewing Automation, Inc. include United Sewing Automation U-325W and United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask.