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This Free of Charge application was designed to help manufacturers, consultants, notified bodies to keep under control the EU declaration of conformity
This software allows you to compose in few minutes declaration of conformity compliant with applicable directives taking under control list of products, declarations of conformity, amended declarations
EN 1618:1997 Standard
Medical devices Directive (93/42/EEC)
Manual wheelchairs - Requirements and test methods
Medical devices Directive (93/42/EEC)
External limb prostheses and external orthoses - Requirements and test methods (ISO 22523:2006)
Medical devices Directive (93/42/EEC)
Respiratory equipment - Infant monitors - Particular requirements (ISO 18778:2005)
Medical devices Directive (93/42/EEC)
Medical devices for conserving oxygen and oxygen mixtures - Particular requirements (ISO 18779:2005)
Medical devices Directive (93/42/EEC)
Non-active surgical implants - Joint replacement implants - Particular requirements (ISO 21534:2007)
Medical devices Directive (93/42/EEC)
Non-active surgical implants - Joint replacement implants - Specific requirements for knee-joint replacement implants (ISO 21536:2...
CELAB is Notified Body No.2037 for the EMC Directive and Italian office of a Notified Body for the RED Directive.
CELAB performs voluntary inspection activities on technical construction files to check their contents.
CELAB can accomplish all the required tests in order to affix the CE-marking related to EMC, LVD, RED, MDD, machines and many others.
CLICK HERE TO GET TESTS AND INFO ON THE EN 1618:1997 STANDARD
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This software allows you to compose in few minutes declaration of conformity compliant with applicable directives taking under control list of products, declarations of conformity, amended declarations