Certifications

Proven excellence and quality

Certifications Filter

Dongguan Manufacturing Factory

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

Dongguan Manufacturing Factory

ISO 9001:2015

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

Dongguan Manufacturing Factory

ISO 13485:2016

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

Dongguan Manufacturing Factory

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.

Dongguan Manufacturing Factory

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.

Mexico Holdings LLC

ISO 9001:2015

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

Mexico Holdings LLC

ISO 13485:2016

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

Mexico Holdings LLC

Automotive Quality Management System

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

Malaysia SDNBHD

ISO 9001:2015

Manufacturing of Electronic Message Displays

Additional certificates

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.

Additional certificates

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.

Design and Build products that matter