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SunTech holds the following certifications:

  • ISO 9001:2008
  • ISO 13485:2003 (EN46001)
  • ANSI/ASQC Q9001-1994 (accredited in 1997)
  • FDA Registered since 1985 (#1036863)
  • All products meet AAMI SP10, EN60601 and EN1060 standards
  • All SunTech Medical Products are CE Marked

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ISO 13485 Certificate of Registration 137.56 KB

ISO 13485 Certificate of Registration for SunTech Medical, Inc. Expires 25SEP2014

Last modified
2011-09-19

ISO 9001 Certificate of Registration 145.28 KB

ISO 9001:2008 Certificate of Registration for SunTech Medical, Inc. Expires 25SEP2014

Last modified
2011-09-19

Japanese PAL Certificate Japanese 156.58 KB

Japanese PAL Certificate of Foreign Manufacturer Accreditation of Medical Devices for SunTech Medical, Inc. Expires 08MAR2012
Last modified
2011-04-28
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