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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 permitted according to MDD 93/42/EEC.

Examination Gloves CE Marking & EU Registartion Process

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

Examination Gloves EU Registration Cost & Timeline

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

 

 

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