WAREMA Press Release

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WAREMA Press Release

WAREMA Receives FDA Approval – Customer Orientation as a Key Success Factor

27 November 2025

WAREMA Headquarters

WAREMA manufactures high-quality plastic components under cleanroom conditions for leading medical and pharmaceutical manufacturers worldwide.

At the request of a customer distributing products in the United States, WAREMA successfully met the stringent requirements for FDA approval, once again demonstrating its strong commitment to customer orientation and quality expertise.

With the official registration at the U.S. Food and Drug Administration (FDA), WAREMA customers now benefit from a significant advantage: components produced by WAREMA can be marketed more easily and quickly in the U.S.

With several production facilities in ISO Class 7 cleanrooms, WAREMA offers extensive capacities, state-of-the-art manufacturing technologies, and the necessary expertise to produce high-precision plastic components and assemblies for medical applications.

Today, with 470 employees, the Kunststofftechnik division founded by WAREMA 33 years ago continues to consistently pursue its growth strategy within the Medical Technology business unit – combined with a clear commitment to further investment in its development and production site in Germany.