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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.

CE Certification For Gloves & EU Registration 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