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
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
- MDSAP 702494
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 | CE 00999.pdf CE 00999.pdf (700.36 KB) |
| Salt Lake City, Utah | MDSAP | SLC MDSAP 688010.pdf SLC MDSAP 688010.pdf (421.29 KB) |
| Liverpool, New York | ISO 13485 | FM 703714.pdf FM 703714.pdf (436.66 KB) |
| Liverpool, New York | MDSAP | |
| 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 | |
| Willich, Germany | CE Certificate | CE 00999.pdf CE 00999.pdf (700.36 KB) |
| 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 (700.36 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) |
| Walluf, Germany | ISO 13485 | MD_697312_SO13485.pdf MD_697312_SO13485.pdf (449.44 KB) |
| Walluf, Germany | MDR Certificate | |
| Las Vegas, Nevada | ISO 9001 | |
| Doetinchem, Netherlands | ISO 9001 | |
| Doetinchem, Netherlands | ISO 13485 | |
| Doetinchem, Netherlands | CE Certificate | |
| Doetinchem, Netherlands | MDSAP | |
| Franklin Park, Illinois | ISO 9001 | ISO9001 Franklin Park ISO9001 Franklin Park (312.3 KB) |
|
Franklin Park, Illinois |
ISO 13485 | |
| Calamba City, Philippines | ISO 9001 | ISO9001 Philippines ISO9001 Philippines (322.69 KB) |
| Calamba City, Philippines | ISO 13485 | ISO 13485_Philippines.pdf ISO 13485_Philippines.pdf (323.36 KB) |
| Beijing, China | ISO 9001 | ISO9001 Beijing ISO9001 Beijing (326.27 KB) |