authorized representative for ce marked medical devices, ivdmia ce marking of medical devices and ce mark for machinery, denovo 510k



List of European Union Directives that require the CE Mark.

  • 73/23/EEC - 2006/95/EC - Electrical Equipment designed for use within certain limits.
  • 87/404/EEC - Simple Pressure Vessels.
  • 88/378/EEC - Safety of Toys.
  • 89/106/EEC - Construction Products.
  • 89/336/EEC - 2004/108/EC - Electromagnetic compatibility.
  • 89/686/EEC - Personal Protective Equipment
  • 90/384/EEC - Non-automatic weighing instruments
  • 90/383/EEC - Active Implantable Medical Devices.
  • 90/396/EEC - Appliances Burning Gaseous Fuels.
  • 92/42/EC - New hot-water boilers fired with liquid or gaseous fuels.
  • 93/15/EEC - Explosives for civil use.
  • 93/42/EC - Medical Devices.
  • 94/9/EC - Equipment and protective systems intended for use in explosive atmospheres.
  • 94/25/EC - Recreational Craft.
  • 95/16/EC - Lifts.
  • 97/23/EC - Pressure Equipment
  • 98/37/EC - Machinery.
  • 98/79/EC - In Vitro diagnostic medical devices.
  • 1999/5/EC - Radio Equipment and telecommunications terminal equipment.
  • 2000/9/EC - Cableway Installations designed to carry persons.
  • 2004/22/EC - Measuring Instruments


  • 2004/108/EC - Replaces 89/336/EEC- July 2007 -
  • 2006/42/EC - Replaces 98/37/EEC - December 2009
  • 2006/95/EC - Replaces 73/23/EEC - January 2007

    • QNET Specializes in cost effective CE marking of Medical Devices, In Vitro Diagnostic Medical Devices, Machinery, Pressure Equipment, and ATEX Equipment.


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    		 ISO 9000 , ISO 13485