Flexan Announces FDA Registration of Manufacturing Facility in Suzhou, China
Lincolnshire, IL. December 10, 2020—Flexan LLC, a leading provider of custom contract manufacturing services for medical device OEM's world-wide has announced the registration of its manufacturing facility in Suzhou, China with the Food and Drug Administration. 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 clean-room 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 4th FDA registered location and will help Flexan expand its offering for costcompetitive manufacturing solutions for class II and class III medical devices. Mike Huiras, Flexan 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 2 decades has prepared us for this next stage in our growth as a global services provider.”
Flexan is a global strategic contract manufacturer of custom high-quality silicone and thermoplastic
components, sub-assemblies, and devices, as well as custom rubber compounding. Flexan provides a
wide range of services, from supporting product design and development, to in-house manufacturing
services including molding, extrusion, assembly and finished packaging. The company operates with a
strict adherence to its robust quality system, while offering reliable fulfillment solutions ranging from
discrete order shipments to full dock: stock solutions.
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