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