Flexan Announces FDA Registration of Manufacturing Facility in China

Flexan LLC, a provider of custom contract manufacturing services for medical device OEMs worldwide has announced the registration of its manufacturing facility in Suzhou, China with the Food and Drug Administration (FDA). Flexan has also successfully registered its first full finished device, which will begin production in Suzhou in early 2021.

Flexan established operations in Suzhou in 2004 and has since expanded its services to provide cleanroom manufacturing for short- and long-term medical devices and components, supporting its global customer base.

Flexan operates with a fully integrated manufacturing platform while providing centers of excellence in manufacturing solutions for silicone, thermoplastic, and custom rubber formulations. The Suzhou location is the company’s fourth FDA registered location and will help Flexan expand its offering for cost competitive manufacturing solutions for Class II and Class III medical devices.

Mike Huiras, Flexan’s vice president of sales and marketing said, “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. 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.”

For more information regarding Flexan’s capabilities, please visit www.flexan.com.