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Confidential Property of Fresenius Kali and its Affiliates Document No.: Revision: Change Order: Title: Page: Last Modified: Color:Code472313373 A CO035068 PRODUCT INSERT PLASMACELLC DISPOSABLE SET

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How to fill out eu declaration of conformity

01

Identify the product and its intended use.

02

Verify that the product complies with relevant EU directives and standards.

03

Gather all required technical documentation, such as test reports and drawings.

04

Prepare the EU Declaration of Conformity document, including all necessary information and signatures.

05

Include a statement declaring that the product meets all relevant requirements and standards.

06

Keep a copy of the EU Declaration of Conformity with the product for at least 10 years.

Who needs eu declaration of conformity?

01

The manufacturer or authorized representative of a product that is subject to EU regulations needs the EU Declaration of Conformity.

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What is eu declaration of conformity?

EU Declaration of Conformity is a document in which the manufacturer declares that the product meets all applicable requirements set out in EU legislation and enables the product to be placed on the market in the European Economic Area (EEA).

Who is required to file eu declaration of conformity?

Manufacturers or their authorized representatives are required to file EU Declaration of Conformity.

How to fill out eu declaration of conformity?

EU Declaration of Conformity can be filled out by providing information about the product, manufacturer, and conformity assessment procedure used to ensure the product complies with applicable requirements.

What is the purpose of eu declaration of conformity?

The purpose of EU Declaration of Conformity is to demonstrate that the product meets all relevant EU requirements and can be placed on the market in the EEA.

What information must be reported on eu declaration of conformity?

The information that must be reported on EU Declaration of Conformity includes details about the manufacturer, product, and the conformity assessment procedure used.

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