Browse through our business library of information relating to regulatory and compliance topics.

Facility

Certificate Name

Certificate

Salt Lake City, Utah ISO 13485
Salt Lake City, Utah ISO 9001
Salt Lake City, Utah CE Certificate
Charleston, South Carolina ISO 13485
Charleston, South Carolina CE Certificate
Willich, Germany ISO 13485
Willich, Germany CE Certificate
Liverpool, New York ISO 13485
Liverpool, New York ISO 9001
Liverpool, New York CE Certificate
Wuxi, Jiangsu, China ISO 13485
Santa Clara, California ISO 13485:2016
Santa Clara, California ISO 13485:2012
Walluf, Germany CE Certificate
Las Vegas, Nevada ISO 9001

 

Varex Imaging Corporation is currently registered or certified under the following regulations and standards:

  • ISO 13485
  • Varex holds an EC certificate under the requirements of Council Directive 93/42/EEC
  • Canadian Medical Device Regulation, P.C.
  • ISO 9001
  • UL/IEC 60601-1
  • CSA 22.2 No. 601.1
  • CFDA
  • Chinese SFDA Registration Nos. 0712278, 0714670, 0004482
  • Japanese PAL/Yakuji-Ho: Controlled MD
  • Russian MHSD: Federal Law No. 184-FZ
     

Salt Lake City, UT

  • FDA 21 CFR, Sub-Chapter J. Initial report number 7410266
  • ISO 9001 Certificate Number FM21804
  • ISO 13485 Certificate Number FM77566
  • CE Mark Certificate Number CE 00999
  • Canadian Medical Device Regulations (CMDCAS)

 

Las Vegas, NV

CE Marking: All Linatron® M™ and K15A™ models are designed, manufactured, and are in conformance with:

  • IEC/EN 61010-1
  • ANSI/UL 61010-1
  • CAN/CSA C22.2 NO. 1010.1-92
  • EMC Directive 2014/30/EU
  • Low Voltage Directive (LVD) 2014/35/EU
  • EN 55011/CISPR 11
  • 2014/35/EU Low Voltage Directive
  • 2014/30/EU EMC Directive


Quality Standard: Varex Imaging Corporation, Las Vegas facility, Quality Management Systems is registered to ISO9001:2008. 
 

Charleston, SC

  • FDA 21 CFR, Sub-Chapter J. Initial report number 8612039
  • ISO 13485 Certificate Number FM84906
  • CE Mark Certificate Number CE 00999

 

Willich, Germany

  • ISO 13485 Certificate Number FM84906
  • CE Mark Certificate Number CE 00999

 

Beijing, China

  • YY/T 0287 Certificate No. 04709Q10016ROS-1
  • Beijing Hua Guang Certification of Medical Devices Co. Ltd. (CMD)


Varex Imaging Corporation complies with requirements of:

  • WEEE (Waste Electrical and Electronic Equipment) Directive 2002/96/EC
  • RoHS (Reduction of Hazardous Substances) Directive 2002/95/EC
  • Administrative Measure on the Control of Pollution Caused by Electronic Information Products, No. 39 (February 2006—People's Republic of China) SJ/TI 1364-2006