CE Marking On Medical Equipments

Additional Details

A FSC is issued by a European Competent Authority upon request by an European Authorized Representative on behalf of a medical device manufacturer. The FSC certifies that your medical device may be legally marketed in the European Union.EAR service can request FSC documents on behalf of our clients. Medical device markets for which Eurotech has secured FSC documents for clients include:

Eurotech Certification has the resources and experience to secure your Free Sale Certificate

Eurotech acts as Authorized Representative(EAR) for many medical device companies selling their products in Europe. In this capacity, Eurotech can request a FSC from the Competent Authority as efficiently and quickly as possible:
Our scope for CE certification by the following directives:

    • Medical Device Directive,
    • Pressure Equipment Directive
    • Transportable Pressure Equipment Directive
    • Simple Pressure Vessels Directive
    • Lift Directive
    • Machinery directive
    • Low Voltage Directive
    • EMC Directive
    • In-vitro Device Directive
    • Active Implantable Medical Device Directive
      Construction Product Directive
      Heavy Machinery/Equipments

We are giving CE Certification on Medical Devices from Italian Notified Body - CERMET. We can provide CE under all class like - Class-1,Class-2 and in Class-3 products.