Follow Us:


Home Examination Gloves CE Marking
Quick Contact
[rt_cf7_style submit_background_color=”#f5f6f6″ submit_hover_color=”#001139″ submit_text_color=”#001a57″ submit_text_hover_color=”#ffffff” radiant_font_color=”#717171″ radius_top=”” radius_right=”” radius_bottom=”” radius_left=”” padding_right=”10px” padding_left=”10px” radiant_border_style=”solid” radiant_border_color=”#e6e6e6″ radiant_border_top=”1px” radiant_border_right=”1px” radiant_border_bottom=”1px” radiant_border_left=”1px” radiant_font_focus_color=”#00174d” radiant_background_focus_color=”#efefef” radiant_focus_style=”solid” radiant_focus_color=”#e6e6e6″ radiant_focus_top=”1px” radiant_focus_right=”1px” radiant_focus_bottom=”1px” radiant_focus_left=”1px” radiant_extra_class=”service-form” cf7_content_css=”.vc_custom_1519126255771{margin-right: 0px !important;margin-left: 0px !important;padding-right: 0px !important;padding-left: 0px !important;}”][/rt_cf7_style]
Need Help?
Technical File Preparation?
Examination Gloves CE Marking

Examination Gloves CE Marking

Examination Gloves CE Marking (Non-Sterile) made in Latex or Nitrile CE Marking and EU Registration is mandatory for marketing in European Economic Area. Examination Gloves are in Class 1 devices so self-declaration is permitted according to MDD 93/42/EEC.

Examination Gloves CE Marking & EU Registartion Process

  • Technical File Development
  • Declaration of Conformity
  • Appoint EAR
  • EU Registration

It is the responsibility of the manufacturer to prepare, maintain and update the technical file. If you are interested to take up the service please find our fees below.


  • Technical File: 2500 Euros in 60 days time (Optional)


The following are the mandatory requirements all foreign exporters must follow


  • Appointment of EU Representative: 650 Euros/year
  • EU Registration Service: 500 / Device


The following are the optional service we provide for the purpose of local marketing.


  • CE Compliance Certificate: 650 Euros (Optional)
  • EU Registration Certificate: 100 Euros

Examination Gloves CE Marking Cost