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CSMi holds both and ISO 13485-2016/MDSAP and EN ISO 13485-2016 registrations
200090H CSMi ISO 13485-2016/MDSAP Certificate of Registration
200402A CSMi EN ISO 13485-2016 Certificate of Registration
200091D HUMAC NORM Intertek EC Certificate
T101-2-3-MED-MDR MDD Extension Confirmation through Dec 31, 2028
200165O HUMAC NORM Declaration of Conformity
200093L TMC Declaration of Conformity
We have completed our Stage 1 MDR audit.
Our Stage 2 audit is scheduled for later this year.
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