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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

 

Bremen, Germany

  • ISO 13485 
  • 93/42/EEC

 

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)
     

Wuxi, Jiangsu, China

  • CE Mark Certificate Number CE 00999


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

Facility

Certificate 

 

Salt Lake City, Utah  
Salt Lake City, Utah  
Salt Lake City, Utah  
Charleston, South Carolina  
Charleston, South Carolina  
Bremen, Germany  
Bremen, Germany  
Bremen, Germany  
Willich, Germany  
Willich, Germany  
Liverpool, New York  
Liverpool, New York  
Liverpool, New York
Wuxi, Jiangsu, China  
Wuxi, Jiangsu, China  
Santa Clara, California  
Santa Clara, California  
Walluf, Germany  
Las Vegas, Nevada  
Dinxperlo, Netherlands  
Dinxperlo, Netherlands