Ace Medical US, LLC
United StatesFDA applicant, unverified
- Devices
- 2
What Ace Medical US, LLC makes
Ace Medical US, LLC manufactures modifications and standalone versions of the Autofuser, a device designed for automated needle attachment and detachment in medical settings, reducing manual handling and improving safety.
The company’s products fall under FDA Class II regulation and are listed via 510(k) clearance in the United States.
Catalogue
Modification To Autofuser Ref K090300
Regimes: 510(k) Registry: 510(k)Autofuser Ref K060258
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Ace Medical Us, LLC have in the registry?
The registry currently lists 2 devices for Ace Medical Us, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Ace Medical Us, LLC's devices?
Among its 2 most recently registered devices, Ace Medical Us, LLC has devices listed in FDA 510(k) (2 devices).
What risk classes do Ace Medical Us, LLC's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Ace Medical Us, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Ace Medical Us, LLC in the registry?
The most recently registered devices listed for Ace Medical Us, LLC include MODIFICATION TO AUTOFUSER and AUTOFUSER.