Resources & Documentation

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)
• MDSAP 688010 

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