Browse through our business library of information relating to regulatory and compliance topics.
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Regulatory Registrations and Certifications
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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
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Regulatory Certificates
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Facility
Certificate Name
Certificate
Salt Lake City, Utah ISO 13485 Salt Lake City, Utah ISO 9001 Salt Lake City, Utah CE Certificate CE 00999 - Varex.pdf
CE 00999 - Varex.pdf (392.73 KB)Charleston, South Carolina ISO 13485 ISO 13485 FM 84906.pdf
ISO 13485 FM 84906.pdf (699.19 KB)Charleston, South Carolina CE Certificate CE 00999 - Varex.pdf
CE 00999 - Varex.pdf (392.73 KB)Bremen, Germany ISO 13485 ISO 13485.pdf
ISO 13485.pdf (205.57 KB)Bremen, Germany ISO 13485 Bremen, Germany 93/42/EEC 93-42-EEC.pdf
93-42-EEC.pdf (199.97 KB)Willich, Germany ISO 13485 ISO 13485 FM 84906.pdf
ISO 13485 FM 84906.pdf (699.19 KB)Willich, Germany CE Certificate CE 00999 - Varex.pdf
CE 00999 - Varex.pdf (392.73 KB)Liverpool, New York ISO 13485 ISO13485.pdf
ISO13485.pdf (437.02 KB)Liverpool, New York CE Certificate Wuxi, Jiangsu, China ISO 13485 Wuxi, Jiangsu, China CE Certificate CE 00999 - Varex.pdf
CE 00999 - Varex.pdf (392.73 KB)Santa Clara, California ISO 13485:2016 Santa Clara, California ISO 13485:2012 Walluf, Germany CE Certificate Las Vegas, Nevada ISO 9001 Dinxperlo, Netherlands ISO 9001 Dinxperlo, Netherlands ISO 13485 -
Anti-Corruption Policies
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Code of Conduct
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