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Regulatory Documentation

We are a leading innovator, developer, and manufacturer of X-ray imaging component solutions worldwide.

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

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

Doetinchem, Netherlands

  • ISO 9001
  • ISO 13485
  • CE Mark Certificate
  • MDSAP Certificate Number BE20/819943983

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

DOWNLOAD / VIEW AS:

  • Salt Lake City, Utah

    ISO 13485

    FM 77566 SLC ISO 13485_2016.pdf

    (519 KB)
  • Salt Lake City, Utah

    CE Certificate

    CE 00999.pdf

    (700 KB)
  • Salt Lake City, Utah

    MDSAP

    SLC MDSAP 688010.pdf

    (421 KB)
  • Liverpool, New York

    ISO 13485

    FM 703714 Liverpool ISO 13485.pdf

    (448 KB)
  • Liverpool, New York

    MDSAP

    MDSAP 702494 - Liverpool NY.pdf

    (435 KB)
  • Liverpool, New York

    CE Certificate

    CE 669061 Liverpool.pdf

    (405 KB)
  • Bremen, Germany

    MDSAP

    2022.02.07 - QS6092_MDSAPe_20220207 - MDSAP gültig 2025.01.27 - - Certificate - PDF

    (443 KB)
  • Bremen, Germany

    MDR (2017/745)

    2022.02.02 - QS6092__AnhIX-Ie_20220207 - MDR QMS gültig 2027.01.27 - - Certificate - PDF

    (452 KB)
  • Bremen, Germany

    MDD 93/42/EEC

    2021.01.18 - QS6092_AnhIIe_20210115 - valid 2024.01.27 - - Certificate - PDF

    (494 KB)
  • Bremen, Germany

    ISO 13485

    ISO 13485.pdf

    (443 KB)
  • Willich, Germany

    CE Certificate

    CE 00999.pdf

    (700 KB)
  • Willich, Germany

    ISO 13485

    ISO-13485 certificate FM 84906 - Willich.pdf

    (442 KB)
  • Wuxi, Jiangsu, China

    ISO 13485

    ISO 13485-2016 MD 644416.pdf

    (490 KB)
  • Wuxi, Jiangsu, China

    CE Certificate

    CE 00999.pdf

    (700 KB)
  • Walluf, Germany

    ISO 9001

    FM_735203_VID_ISO9001_exp_2024_01_04.pdf

    (513 KB)
  • Walluf, Germany

    ISO 13485

    MD_697312_SO13485.pdf

    (449 KB)
  • Walluf, Germany

    MDR Certificate

    EU_Cert_MDR725323_VarexImagingDeutschlandAG.pdf

    (386 KB)
  • Las Vegas, Nevada

    ISO 9001

    FM 80701_ISO_Cert_Ex-02-Dec-2024

    (81 KB)
  • Doetinchem, Netherlands

    ISO 9001

    Varex Imaging Nederland B.V._BE ISO9001 29-11-2020.pdf

    (807 KB)
  • Doetinchem, Netherlands

    ISO 13485

    Varex Imaging Nederland B.V._BE ISO 13485 24-11-2020.pdf

    (141 KB)
  • Doetinchem, Netherlands

    CE Certificate

    Varex Imaging Group Nederland B.V._BE 93 42 EEC 24-11-2020.pdf

    (257 KB)
  • Doetinchem, Netherlands

    MDSAP

    Varex Imaging Group Nederland B.V._BE AND 0-1146.QMD_MDSAP 03-02-2021.pdf

    (268 KB)
  • Franklin Park, Illinois

    ISO 9001

    ISO9001 Franklin Park

    (312 KB)
  • Franklin Park, Illinois

    ISO 13485

    ISO 13485_Franklin_Park.pdf

    (317 KB)
  • Calamba City, Philippines

    ISO 9001

    ISO9001 Philippines

    (323 KB)
  • Calamba City, Philippines

    ISO 13485

    ISO 13485_Philippines.pdf

    (323 KB)
  • Beijing, China

    ISO 9001

    ISO9001 Beijing

    (326 KB)