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Declaration of Conformity
We hereby declare that the product listed below complies with the essential requirements of the Medical Device
Directive: 93/42/EEC and RoHS Directive: 2011/65/EU based on category 8 of Annex I.
Product : DENTAL UNIT (CLASS IIa)
Model
: CLEST
AⅡ
" CLASS IIa " has been de
fi
ned by the rule 9 of MDD Annex IX.
The product has been designed and manufactured in accordance with the European standards as the listed in the
Declaration of Conformity.
Our full quality assurance system has been approved to MDD ANNEX II, excluding section 4 (Registration
No. HD 60143723 0001) by Noti
fi
ed Body, TUV Rheinland LGA Products GmbH (NO.0197).