Invent Medic announces that the company has appointed EMERGO by UL as its US representative in FDA-related matters, including the company’s upcoming 510(k) application for Efemia bladder support.
As previously stated, Invent Medic is planning to submit a so-called 510(k) application for its product Efemia bladder support to the FDA in 2020. A 510(k) approval grants the right to market the product in the United States. This process has now taken another step forward, as Invent Medic has signed an agreement with EMERGO by UL that will act as the company’s representative during the application process.
“It is inspiring that we have now taken another step closer to the market registration and launch of Efemia in the United States, which is expected to become the second major market for the product after Europe. EMERGO by UL is a well-established firm with substantial regulatory experience in the medical technology segment,” says Invent Medic’s CEO Karin Bryder.
About Emergo by UL
EMERGO by UL is a leading regulatory consulting firm specializing in global medical device and IVD compliance. Their comprehensive solution is designed to help companies to achieve and maintain regulatory and commercial success. With a presence on six continents, they can provide real-time service and on-the-ground expertise. Learn more at EMERGObyUL.com.
This disclosure contains information that Invent Medic Sweden is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 22-10-2020 20:21 CET.