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Certifications

Full Experience of Medical Certifications

No need to worry about the problem of getting documents. With internal and external test laboratories, our experienced LAB engineers with more 10 years make sure your product certified.
Onyx can help you bring your market to USA, Europe and China quickly.

  • ISO 9001:2015

    Onyx meets specifies requirements of ISO 9001:2015 for a quality management system where an organization from 2011/08/02.

    Valid until: 27, February , 2025

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  • ISO14001:2015

    Onyx meets specifies requirements of ISO 14001:2015 for Environmental requirements, where an organization from February 2016.
    Environmental Policy:
    Green Manufacturing, Environmental Innovation, Sustainable ,Development Continuous Improvement

    Valid until: 19, February , 2022 ~ 19, February , 2025

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  • ISO 13485:2016

    Onyx meets specifies requirements of ISO 13485:2016 for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services from 2011/08/02.

    Valid: 28, February , 2022 — 27, February , 2025

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  • FCC

    All of onyx's products comply with FCC Part 18.

  • CE

    EN 60601-1-2: 2015 + A1: 2021 (V4.1),        
    EN 60601-1: 2007 + A1:2013 +A2:2021 (V3.2)      
    EN 55032:2015/A1:2020
    EN 55035:2017/A11:2020 (ITE)
    IEC 62368-1:2020+A11:2020 (ITE)

  • UL : ANSI AAMI ES60601-1:2005/A1:2012/A2:2021(V3.2)

    All of onyx's products have got the UL certificate.

  • cUL : CAN/CSA-C22.2 No. 60601-1:14 (IEC 60601-1: 2005+A1:2012+A2:2020,MOD) (V3.2)

  • TELEC

    JAPAN TELEC

  • CCC

    Some of Onyx products meets the CCC mark is required for both Chinese manufactured and foreign imported products.

  • ENERGY STAR

    Venus-224/244 and MATE2-2210/2410 are ENERGY STAR qualified products. Power management settings are enabled by default, allowing the display and computer to automatically enter a low-power “sleep mode” within fifteen or thirty minutes of user inactivity, respectively. The devices can be woken from sleep mode in response to a command from the power button, keyboard, mouse or the network (Wake on LAN).

  • Clorox Healthcare Compatibility Program

    Onyx Products Approved Clorox Healthcare Compatible™ for Safer Medical Environments

Onyx Healthcare is the first company with EMC 4.0 / Safe 3.1 ready products

In the European Union, the Date of Withdrawal (DoW) of EN 60601-1:2006 (Safety Edition 3.0) is published as Dec. 31st 2017 and DoW of EN 60601-1-2:2007(EMC Edition 3.0) is published as Dec. 31st 2018.
All devices manufactured and imported into the EU are required to comply with EN 60601-1:2006/A1:2013 (Safety Edition 3.1) after year 2018 and EN 60601-1-2:2015 (EMC Edition 4.0) after year 2019.
All Onyx products in mass production are compliant to Safety Edition 3.1 and EMC Edition 4.0 and please refer to the following product list.

Privacy Policy

  1. Introduction Thank you for visiting Onyx Healthcare Inc. Your personal privacy is absolutely respected and protected by the website. To help you understand how the website collects, uses and protects your personal information, be sure to read the website "Privacy Policy". Thank you!
  2. Scope of Application 1. Applicable: on "Onyx website" or its related activities involving personal information collecting, using, and protecting. 2. Not Applicable: an independent management and operation third-party website linked thru Onyx website . Each website has own unique privacy policy, so the liability is separated. When users make an inquiry on these websites, be sure to follow the particular website's privacy policy for all personal information.
  3. Policy Content
    1. Collect Information:
      • For the simple Onyx website browsing and file downloading, users will not be collected for any personal information.
      • The website will record user IP address, time of Internet access, and the number of information search.
      • When using various services on Onyx website, such as quote inquiry, we will ask users to provide the full name, phone, fax, e-mail and the respective authorities.
    2. Use Information: Due to website internal management, by user's website access information, website traffic and online behavior can be processed as a "total analysis" for the important reference to enhance service quality, and this analysis will not apply to any "individual user".
    3. Information Sharing: Unless your agreement or special law regulations, Onyx Healthcare Inc. will never sell, exchange, or rent any of your personal information to other groups, individuals or private companies However, except for the following circumstances:
      • Cooperate with the lawful administration of justice if needed.
      • Cooperate with the related authorities in accordance with operational needs for investigation or use.
      • Disclosure is required by law, or for maintenance, improvement and management of the website service.
    4. Cookies on Your Browser File:
      • To provide a better, a more personalized service, and to facilitate your participation in activities, cookies changes as your personal activities on the website change.
      • In order to count the number of visitors and analyze browsing patterns to understand the state of web browsing, the website will hold on the principle of privacy protection to write and read cookies in your browser.
  4. Consultation If you have any questions or comments regarding the privacy policy on this website, please email or call to contact us.
  5. Revision of Privacy Policy Privacy Policy of this website will be revised at any time in response to demand. As revision takes place, the new terms will be published on the website.

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