CERTIFICATION

CE

European Conformity

Applicable products carry CE marking under the European regulatory framework, supported by Technical Documentation, risk management files, clinical evaluation and applicable conformity assessment routes.

  • Compliance with the EU Medical Devices Regulation framework where applicable
  • RoHS, REACH and EMC compliance for electrical products
  • Declaration of Conformity and supporting technical file available for partners

Need the Full Compliance Dossier?

Request the complete CE certificate package, scope of registration and supporting test reports for your market entry review.

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