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This document certifies that Welch Allyn SureTemp® Plus (690 & 692) and related accessories comply with the required European Medical Device Directives and RoHS provisions.
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How to fill out declaration of conformity
How to fill out declaration of conformity
01
Identify the product that requires the declaration of conformity.
02
Ensure that the product complies with the relevant EU directives or regulations.
03
Gather all necessary technical documentation that demonstrates compliance.
04
Identify and describe the standards that the product meets.
05
Complete the declaration of conformity form, including the manufacturer's details and product information.
06
State the relevant directives to which the product conforms.
07
Sign and date the declaration, certifying that the information provided is accurate.
Who needs declaration of conformity?
01
Manufacturers of products sold within the European Economic Area.
02
Importers placing products in the market within the EU.
03
Distributors who are responsible for ensuring products comply with safety standards.
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What is declaration of conformity?
A declaration of conformity is a legal document that confirms a product meets the required standards and regulations set by relevant authorities, ensuring it is safe for use and compliance with applicable directives.
Who is required to file declaration of conformity?
Manufacturers, importers, or authorized representatives of a product are required to file a declaration of conformity when they place a product on the market within certain jurisdictions.
How to fill out declaration of conformity?
To fill out a declaration of conformity, provide details about the manufacturer, the product, applicable standards and directives, and sign the document to validate compliance.
What is the purpose of declaration of conformity?
The purpose of a declaration of conformity is to assure customers and regulatory bodies that a product complies with specific safety and quality standards, enabling free movement of goods within the market.
What information must be reported on declaration of conformity?
The declaration of conformity must include the name and address of the manufacturer, product description, relevant standards and directives, date of issue, and signature of the responsible person.
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