ISO 13485 approven products and CE Certificates

Colenta Labortechnik GmbH & Co KG take pride in their qualification as an approved manufacturer to ISO 13485 standard. ISO 13485 status confirms our commitment to maintain the highest standards demanded by our customers in both the quality of our products and the services we provide.

 

Quality Management System EN ISO 13485:2016

Quality Management System

CE Certificate for X-Ray Films - Directive 93/42/EEC Annex V - Section 3

CE Certificate X-Ray Films

CE Certificate for Digital X-Ray - Directive 93/42/EEC Annex II - excluding Section 4

CE Certificate Digital X-Ray

Files CE Certificates

Filename
An Adobe Acrobat file MDC Certificate Digital X-ray - D4004500008_D
An Adobe Acrobat file MDC Certificate Digital X-ray - D4004500008_E
An Adobe Acrobat file MDC Certificate X-Ray Films - D4004500007_E
An Adobe Acrobat file MDC_Certificate_ISO_13485-D4004500009_D
An Adobe Acrobat file MDC_Certificate_ISO_13485-D4004500009_E