Remade USA, LLC
Country not established
- Devices
- 1
What Remade USA, LLC makes
Remade USA, LLC manufactures surgical masks designed for medical and procedural use, providing barrier protection against airborne contaminants.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Surgical Mask Ref K212451
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Remade USA, LLC have in the registry?
The registry currently lists 1 device for Remade USA, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Remade USA, LLC's devices?
Among its 1 most recently registered device, Remade USA, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do Remade USA, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for Remade USA, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Remade USA, LLC in the registry?
The most recently registered devices listed for Remade USA, LLC include Surgical Mask.