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Certificates & Conformity
EC-Certificate
Product Quality Assurance System
Directive 93/42/EWG on Medical Devices (MDD), Annex VI (Devices in class IIa or IIb)
QM-Certificate
EN ISO 13485:2016 Medical Devices Quality management systems – Requirements for regulatory purposes
CB Test Certificate
IEC 60601-1 (ed.3); am1
IEC 60601-1-6 (ed.3);am1
IEC62366 (ed.1);am1
