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Regulatory Documents/Certificates |
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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 SunTechMedical Products are CE Marked.
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