Certifications

Proven excellence and quality

Dongguan Manufacturing Factory

ISO 14001:2015

ISO 14001:2015

Manufacturing of Inductors, Transformers, Alternating Current Adapters, LED Drivers; Printed Circuit Board Assemblies; Line Module and Universal Surge Protectors for Communication Devices; Magnetic Locks; Plastic Injection Components, Metal Stamping Components & Molds

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ISO 9001:2015

ISO 9001:2015

Manufacture of alternating current adaptors, inductors, transformers, print circuit board assemblies and injection plastic products

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ISO 13485:2016

ISO 13485:2016

Manufacture of patient movement monitors, non-sterile anesthesia masks, Electronic Suction Unit

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ISO 45001:2018

ISO 45001:2018

Manufacturing of Inductors, Transformers, Alternating Current Adapters, LED Drivers; Printed Circuit Board Assemblies; Line Module and Universal Surge Protectors for Communication Devices; Magnetic Locks; Plastic Injection Components, Metal Stamping Components & Molds

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FDA Registered Facility

FDA Registered Facility

FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the Federal Food, Drug, and Cosmetic Act.

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Lake Zurich Headquarters

ISO 9001:2015

ISO 9001:2015

Warehouse and distribution of electro-mechanical assemblies and sub-assemblies, plastic parts and assemblies.

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Mexico Holdings LLC

ISO 9001:2015

ISO 9001:2015

Warehouse and distribution of electro-mechanical assemblies and sub-assemblies, plastic parts and assemblies.

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ISO 13485:2016

ISO 13485:2016

Warehouse and distribution of parts and the contact manufacture of electromechanical and mechanical assemblies and products for the medical device industry.

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Quality Management System certificate

Automotive Quality Management System

Manufacture of printed circuit boards and electromechanical assemblies. Permitted Exclusion: Product Design

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Malaysia SDN BHD

ISO 9001:2015

ISO 9001:2015

Manufacturing of Electronic Message Displays

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Additional certificates

Quality System (QS) Regulation

Quality System (QS) Regulation

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices.

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DODD-FRANK ACT (SEC 1502)

DODD-FRANK ACT (SEC 1502)

Eastek International is committed to ensuring that all materials or components procured from suppliers comply with the Dodd-Frank Act’s rules regarding Conflict Minerals. Eastek is carefully monitoring developments in our supply chain to meet our customer requirements and compliance with this Act.

Dongguan Manufacturing Factory

ISO 14001:2015

ISO 14001:2015

Manufacturing of Inductors, Transformers, Alternating Current Adapters, LED Drivers; Printed Circuit Board Assemblies; Line Module and Universal Surge Protectors for Communication Devices; Magnetic Locks; Plastic Injection Components, Metal Stamping Components & Molds

dark arrow top right
ISO 9001:2015

ISO 9001:2015

Manufacture of alternating current adaptors, inductors, transformers, print circuit board assemblies and injection plastic products

dark arrow top right
ISO 13485:2016

ISO 13485:2016

Manufacture of patient movement monitors, non-sterile anesthesia masks, Electronic Suction Unit

dark arrow top right
ISO 45001:2018

ISO 45001:2018

Manufacturing of Inductors, Transformers, Alternating Current Adapters, LED Drivers; Printed Circuit Board Assemblies; Line Module and Universal Surge Protectors for Communication Devices; Magnetic Locks; Plastic Injection Components, Metal Stamping Components & Molds

dark arrow top right
FDA Registered Facility

FDA Registered Facility

FDA identifies standards to which manufacturers of medical devices may submit a declaration of conformity to demonstrate they have met relevant requirements in the Federal Food, Drug, and Cosmetic Act.

dark arrow top right

Lake Zurich Headquarters

ISO 9001:2015

ISO 9001:2015

Warehouse and distribution of electro-mechanical assemblies and sub-assemblies, plastic parts and assemblies.

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Mexico Holdings LLC

ISO 9001:2015

ISO 9001:2015

Warehouse and distribution of electro-mechanical assemblies and sub-assemblies, plastic parts and assemblies.

dark arrow top right
ISO 13485:2016

ISO 13485:2016

Warehouse and distribution of parts and the contact manufacture of electromechanical and mechanical assemblies and products for the medical device industry.

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Quality Management System certificate

Automotive Quality Management System

Manufacture of printed circuit boards and electromechanical assemblies. Permitted Exclusion: Product Design

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Malaysia SDN BHD

ISO 9001:2015

ISO 9001:2015

Manufacturing of Electronic Message Displays

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