Swedish Trade Council USA
Country not established
- Devices
- 2
What Swedish Trade Council USA makes
The company manufactures sterile ultrasound transmission gel, a coupling medium used to enhance imaging during ultrasound procedures, and the Renalyzer PRX 90, a device for analyzing urine samples to detect and quantify protein levels.
These products are classified as Class II medical devices and are listed under FDA’s 510(k) clearance process. The company operates from the United States.
Catalogue
Sterile Ultrasound Transmission Gel Ref K894490
Regimes: 510(k) Registry: 510(k)Renalyzer Prx 90 Ref K903034
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Swedish Trade Council USA have in the registry?
The registry currently lists 2 devices for Swedish Trade Council USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Swedish Trade Council USA's devices?
Among its 2 most recently registered devices, Swedish Trade Council USA has devices listed in FDA 510(k) (2 devices).
What risk classes do Swedish Trade Council USA's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Swedish Trade Council USA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Swedish Trade Council USA in the registry?
The most recently registered devices listed for Swedish Trade Council USA include STERILE ULTRASOUND TRANSMISSION GEL and RENALYZER PRX 90.