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 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_ISO_13485-D4004500009_D
An Adobe Acrobat file MDC_Certificate_ISO_13485-D4004500009_E
An Adobe Acrobat file MDC_Notified_Body_Confirmation_Letter_Digital_X-ray-D4004500010_E
An Adobe Acrobat file OLD_MDC_Certificate_X-Ray_Films_-_D4004500007_E