LINCOLNSHIRE, Ill.—Medical device contract manufacturer Flexan L.L.C. has registered its manufacturing facility in Suzhou, China, with the Food and Drug Administration, the company said in a statement.
It also successfully has registered its first full finished device, which will begin production in Suzhou in early 2021, Flexan said.
Flexan established operations in Suzhou in 2004 and since has expanded to provide clean-room manufacturing for short- and long-term medical devices and components for its global customer base.
Flexan operates with a fully integrated manufacturing platform while providing manufacturing solutions for silicone, thermoplastic and custom rubber formulations.
The Suzhou location is the company's fourth FDA registered location.
"This registration represents another effort by Flexan to meet the needs of our global customer base and support their desire for high-quality, cost-competitive medical devices," said Mike Huiras, Flexan's vice president of sales and marketing. "We are confident that our dedicated team in Suzhou is prepared to support our first full device production program, along with additional new business we expect to support in Suzhou in the future. Our experience operating in China for nearly two decades has prepared us for this next stage in our growth as a global services provider."