Regulatory Documentation

Regulatory Registrations and Certifications

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
  • China NMPA Order No. 680 China Regulations on Supervision and Administration of Medical Device
  • China NMPA Order No. 4 Provisions for Medical Device Registration
  • 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 13485 Certificate Number FM77566
  • CE Mark Certificate Number CE 00999
  • Canadian Medical Device Regulations (CMDCAS)
  • MDSAP 688010 

 

Las Vegas, NV

CE Marking: All Linatron® M/Mi-Series™, SSM™ and K15™ models are designed, manufactured, and are in conformance with: 

  • IEC/EN/UL 61010-1 
  • EN 55011/CISPR 11
  • 2014/35/EU Low Voltage Directive 
  • 2014/30/EU EMC Directive 
  • 2011/65/EU RoHS Directive  

 

Charleston, SC

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

 

Liverpool, NY

  • FDA 21 CFR, Sub-Chapter J. Initial report number 1830283
  • ISO 13485:2016 Certificate Number FM703714
  • CE Mark Certificate Number CE 669061
  • Canadian Medical Device Regulations (CMDCAS)
  • IEC 60601-1-2 Ed. 4.0
  • IEC 60601-2-54 Ed. 1.1
  • ANSI AAMI ES60601-1
  • IEC 60601-1-2 Ed. 3
  • IEC 60601-1-6 Ed. 3.1
  • ANSI AAMI IEC 62366-1
  • EC 62304 Ed. 1.1
  • NEMA DICOM Standard

 

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
  • ISO 13485 Certificate Number MD644416


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

 

Regulatory Certificates

 

Facility

Certificate Name

Certificate
Salt Lake City, Utah ISO 13485
Salt Lake City, Utah CE Certificate
Salt Lake City, Utah MDSAP
Charleston, South Carolina ISO 13485
Charleston, South Carolina CE Certificate

CE 00999.pdf

CE 00999.pdf (398.37 KB)
Liverpool, New York ISO 13485
Bremen, Germany ISO 13485
Bremen, Germany ISO 13485
Bremen, Germany 93/42/EEC
Willich, Germany ISO 13485
Willich, Germany CE Certificate

CE 00999.pdf

CE 00999.pdf (398.37 KB)
Liverpool, New York CE Certificate
Wuxi, Jiangsu, China ISO 13485
Wuxi, Jiangsu, China CE Certificate

CE 00999.pdf

CE 00999.pdf (398.37 KB)
Santa Clara, California ISO 13485
Walluf, Germany CE Certificate
Las Vegas, Nevada ISO 9001
Dinxperlo, Netherlands ISO 9001
Dinxperlo, Netherlands ISO 13485
Dinxperlo, Netherlands Directive
Franklin Park, Illinois ISO 9001

Franklin Park, Illinois 

 ISO 13485
Calamba City, Philippines ISO 9001
Calamba City, Philippines ISO 13485
Beijing, China ISO 9001