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CERTIFICATE The Notified Body 0036 of TV SD Industrie Service GmbH certifies thatSAFAS S.p.A. Via Verona, 23 IT 36077 Tavernelle di Altavilla (VI) has implemented, operates and maintains a Quality

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Obtain the necessary documentation and information required by the notified body.

02

Fill out the application form accurately and completely.

03

Submit the application form along with all supporting documents to the notified body.

04

Await confirmation from the notified body regarding the approval of the application.

Who needs new notified body for?

01

Manufacturers of medical devices who wish to sell their products in the European Union.

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What is new notified body for?

The new notified body is designated to assess the conformity of certain products and ensure they meet the necessary regulations and standards before being placed on the market.

Who is required to file new notified body for?

Manufacturers or importers of certain regulated products are required to file with a new notified body to demonstrate compliance with regulatory requirements.

How to fill out new notified body for?

To fill out the new notified body form, applicants must provide detailed information about the product, the intended use, relevant specifications, and any existing compliance documentation.

What is the purpose of new notified body for?

The purpose of the new notified body is to ensure product safety and compliance with regulatory standards, thereby protecting consumers and facilitating trade within the market.

What information must be reported on new notified body for?

Information that must be reported includes product details, manufacturer's information, test results, risk assessment, and compliance with applicable standards.

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