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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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Category: EU

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Declaration of Conformity for Advantage 20.81 KB

Declaration of Conformity for Advantage OEM Modules

Last modified
2011-08-19

Declaration of Conformity for Advantage+ 30.38 KB

Declaration of Conformity for Advantage+

Last modified
2011-08-19

Declaration of Conformity for All Purpose Cuffs 26.6 KB

Declaration of Conformity for All Purpose Cuffs, MDD Annex VII

Last modified
2011-08-19

Declaration of Conformity for Cycle 37.56 KB

Declaration of Conformity for Cycle Stress BP device, MDD Annex II

Last modified
2011-08-19

Declaration of Conformity for Disposable Cuffs 30.72 KB

Declaration of Conformity for Disposable Cuffs, MDD Annex VII

Last modified
2011-08-19

Declaration of Conformity for Eclipse Cuffs 28.93 KB

Declaration of Conformity for Eclipse Cuffs, MDD Annex VII

Last modified
2011-08-19

Declaration of Conformity for Kadenz 29.7 KB

Declaration of Conformity for Kadenz OEM BP Module

Last modified
2011-08-19

Declaration of Conformity for Orbit Cuffs 29.85 KB

Declaration of Conformity for Orbit Cuffs, MDD Annex VII

Last modified
2011-08-19

Declaration of Conformity for Orbit-K 29.63 KB

Declaration of Conformity for Orbit-K Cuffs, MDD Annex VII

Last modified
2011-08-19

Declaration of Conformity for Oscar 2 31.46 KB

Declaration of Conformity for Oscar 2 ABP device, MDD Annex II

Last modified
2011-08-19

Declaration of Conformity for Shape 222B/PressureTrak 30.84 KB

Declaration of Conformity for Shape 222B/PressureTrak ABP Device, MDD Annex II

Last modified
2011-08-19

Declaration of Conformity for SunTech 247 32.51 KB

Declaration of Conformity for SunTech 247 Diagnostic station, MDD Annex II

Last modified
2011-08-19

Declaration of Conformity for Tango+ 27.65 KB

Declaration of Conformity for Tango+ Stress BP Device, MDD Annex II

Last modified
2011-08-19

EC Certificate 15.04 KB

EC Certificate for SunTech Medical, Inc.  Full Quality Assurance System
Last modified
2011-07-27

MDD Product List 13.49 KB

Listing of all products covered under the EC certificate

Last modified
2011-08-05
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