Home > About ANKE > Quality Certifications

    ANKE is committed to providing high quality products and services for customers since its inception. It has established a comprehensive and scientific management system of R&D, manufacture, and operation, and has obtained TUV ISO9001: 1994 Certification, CE mark and approved by FDA.
 
    1997           Quality System Certification of GB/T 19001-1994-ISO9001:1994 and YY/T0287-1996-ISO13485:1996 of CMDC
    2000           Quality Assurance Certification of ISO 9001:1994 of TUV, Germany
    2000           CE Mark for MRI Systems
    2000           CE Mark for CT Enhancement Injector
    2000           CE Mark for Mammography
    2003           Quality System Certification of GB/T 19001-2000 idt ISO9001:2000
    2006           Quality System Certification of YY/T 0287-2003 idt ISO13485:2003
    2009           Quality System Certification of ISO9001:2008 and ISO13485:2003
    2011           CE Mark for Digital Radiography System
    2012           MRI system has gotten FDA 510(k) Clearances Letter and been approved to market in the U.S.


ISO 13485
                                                                                       ISO 9001
      


CE
      


FDA