Molex Inc.’s China facility, Molex Dongguan, is now registered with the U.S. Food and Drug Administration (FDA) as a compliant manufacturer of class I medical devices. Manufacturers involved in the production and distribution of medical devices intended for use in the United States must register annually with the FDA regulatory agency, which is under the auspices of the U.S. Department of Health and Human Services.

Molex makes electronic solutions and is headquartered in Lisle, Ill.

“As a trusted partner providing integrated solutions for disposable patient sensors and other medical products, we are pleased to give Molex customers the added assurance of U.S. FDA registration,” said Justin Spitzer, business development manager of Molex. “Molex Dongguan adheres to stringent quality systems that ensure our products meet or exceed FDA class I standards and requirements for medical devices used in the care of patients.”

Part of an ongoing process improvement plan by the Molex printed circuit products group, U.S. FDA registration confirms the Dongguan China site’s adherence with FDA inspections, tracking and traceability criteria. Molex Dongguan and other Molex manufacturing facilities maintain certification in ISO 9001 quality management and ISO 14001 environmental management.

“Molex enables medical device designs that drive healthcare innovation. Patient monitors are evolving from bedside equipment to smaller, lightweight, integrated solutions,” added Spitzer. “As high volume markets expand for portable and wearable patient monitors requiring quality disposable sensors, we are pleased to provide medical device manufacturers the quality FDA registered products they need at a competitive price point.”

Molex makes interconnect technology for markets including data communications, telecommunications, scientific, consumer electronics, industrial, automotive, commercial vehicle, aerospace and defense, medical and lighting.