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Regulatory Documents/Certificates
Regulatory Documents/Certificates

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 SunTechMedical Products are CE Marked.

 

NameSizeType
PDF247 Japanese License Certificate715 KBPDF
PDFCert CMDL BP Calibration Kits40 KBPDF
PDFCert CMDL SunTech 247 BP112 KBPDF
PDFCert CMDL SunTech 247 BP, SpO2, With/without Temp48 KBPDF
PDFCert CMDL SunTech 247 Temp Module38 KBPDF
PDFCert EC 93/42 EEC15 KBPDF
PDFCert ISO 9001:200838 KBPDF
PDFCert_CMDL_ABPM1.9 MBPDF
PDFCert_CMDL_APC54 KBPDF
PDFCert_CMDL_Accutracker1.9 MBPDF
PDFCert_CMDL_Eclipse859 KBPDF
PDFCert_CMDL_Orbit802 KBPDF
PDFCert_CMDL_OscABPM229 KBPDF
PDFCert_CMDL_Tango1.9 MBPDF
PDFCert_CMDL_TangoPlus49 KBPDF
PDFCert_CMDL_xpod21 KBPDF
PDFCert_FG380 KBPDF
PDFCert_ISO13485_200368 KBPDF
PDFCert_Japan_PAL157 KBPDF
PDFDeclaration Of Conformity For Accutracker278 KBPDF
PDFDeclaration Of Conformity For Advantage301 KBPDF
PDFDeclaration Of Conformity For Advantage+277 KBPDF
PDFDeclaration Of Conformity For All Purpose Cuffs26 KBPDF
PDFDeclaration Of Conformity For Cycle314 KBPDF
PDFDeclaration Of Conformity For Eclipse24 KBPDF
PDFDeclaration Of Conformity For Kadenz280 KBPDF
PDFDeclaration Of Conformity For Orbit22 KBPDF
PDFDeclaration Of Conformity For Orbit-K22 KBPDF
PDFDeclaration Of Conformity For Oscar2297 KBPDF
PDFDeclaration Of Conformity For PressureTrak18 KBPDF
PDFDeclaration Of Conformity For Shape 222B24 KBPDF
PDFDeclaration Of Conformity For Shape 222C17 KBPDF
PDFDeclaration Of Conformity For SunTech 247293 KBPDF
PDFDeclaration Of Conformity For Tango303 KBPDF
PDFDeclaration Of Conformity For Tango+304 KBPDF
PDFMDD Product List13 KBPDF