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
- 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
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
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 | FM 77566 (1).pdf FM 77566 (1).pdf (436.4 KB) |
| Salt Lake City, Utah | ISO 9001 | |
| Salt Lake City, Utah | CE Certificate | CE 00999.pdf CE 00999.pdf (417.24 KB) |
| Salt Lake City, Utah | MDSAP | |
| 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.pdf CE 00999.pdf (417.24 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.pdf CE 00999.pdf (417.24 KB) |
| Liverpool, New York | ISO 13485 | |
| Liverpool, New York | CE Certificate | CE 669061 Liverpool.pdf CE 669061 Liverpool.pdf (405.11 KB) |
| Wuxi, Jiangsu, China | ISO 13485 | |
| Wuxi, Jiangsu, China | CE Certificate | CE 00999.pdf CE 00999.pdf (417.24 KB) |
| Santa Clara, California | ISO 13485 | MD 697312.pdf MD 697312.pdf (718.49 KB) |
| Walluf, Germany | CE Certificate | CE 697335 Walluf.pdf CE 697335 Walluf.pdf (407.67 KB) |
| Las Vegas, Nevada | ISO 9001 | |
| Dinxperlo, Netherlands | ISO 9001 | |
| Dinxperlo, Netherlands | ISO 13485 | |
| Dinxperlo, Netherlands | Directive |