Amedic AB
SwedenFDA applicant, unverified
- Devices
- 1
What Amedic AB makes
Amedic AB manufactures ultrasound transducer covers, designed to protect imaging devices during use while maintaining signal integrity. These covers are intended for single-use applications in medical imaging procedures, ensuring hygiene and compatibility with various transducer types.
The company’s products fall under FDA Class II devices and are listed via 510(k) clearance in the United States. The manufacturer is based in the US, adhering to regulatory requirements for medical device compliance in that jurisdiction.
Catalogue
Everytime Transfucer Cover Ref K955893
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Amedic AB have in the registry?
The registry currently lists 1 device for Amedic AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Amedic AB's devices?
Among its 1 most recently registered device, Amedic AB has devices listed in FDA 510(k) (1 device).
What risk classes do Amedic AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Amedic AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Amedic AB in the registry?
The most recently registered devices listed for Amedic AB include EVERYTIME TRANSFUCER COVER.