REGULATORY DOCUMENTATION

Regulatory Registrations and Certifications

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

• ISO 13485
• Varex Imaging 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

Conflict Minerals Report

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
• Medical Devices Regulations (SOR/98-282)
• 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

Liverpool, NY

• ISO 13485:2016 Certificate Number FM703714
• CE Mark Certificate Number CE 669061
• MDSAP 702494

Bremen, Germany

• ISO 13485 
• 93/42/EEC

Willich, Germany

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

Doetinchem, Netherlands

• ISO 9001
• ISO 13485
• CE Mark
• MDSAP

Danderyd, Sweden

• ISO 13485

Espoo, Finland

• ISO 13485

London, United Kingdom

• ISO 13485

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
• MDSAP

Pune, India

• ISO 13485

Varex Imaging Corporation complies with requirements of:

• WEEE (Waste Electrical and Electronic Equipment) DIRECTIVE 2012/19/EU
• 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