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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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247 Japanese License Certificate Japanese 715.45 KB

Certificate of license authorizing sale of the 247 in Japan
Last modified
2011-07-27

Japanese PAL Certificate Japanese 30.42 KB

Japanese PAL Certificate of Foreign Manufacturer Accreditation of Medical Devices for SunTech Medical, Inc.

Last modified
2012-05-01
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