Products distributed by Private Practice Solutions (“PPS”) are required to carry a CE marked and cleared for sale in the EU. For countries where specific national approvals or clearances are required (for example by the FDA in the United States), some of the products and/or applications may not have been cleared yet, although they may be allowed for sale under a manufacturer’s IRB for MD participants only.
Similarly, local patents may limit usage for certain technologies and applications. Please check with your local PPS rep, the manufacturer, and your national regulatory body to find out whether a specific product or application is available for sale and use in your state or country.