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DocuSign Envelope ID: 3CBDC7D71C854F53B7E464D8337F56A2Malta, 11th May 2022 Aspire Global PLC Minutes of the extraordinary general meetingDate and time: 11 May 2022, 14:00 CEST Venue: Aspire Global

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How to fill out masimo announces ce marking

01

Begin by gathering all necessary documentation and information related to the product being certified.

02

Complete the necessary conformity assessment procedures as outlined by the CE marking regulations.

03

Prepare a technical file that includes all relevant documentation and test reports to support the product's compliance with regulations.

04

Complete the Declaration of Conformity and affix the CE marking to the product.

05

Ensure ongoing compliance with CE marking requirements through regular testing and quality control measures.

Who needs masimo announces ce marking?

01

Any manufacturer or distributor of medical devices that are sold or distributed in the European Economic Area (EEA) needs to obtain CE marking for their products.

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What is masimo announces ce marking?

Masimo announces CE marking refers to the certification process where Masimo, a medical technology company, receives a CE mark for its products, indicating compliance with European health, safety, and environmental protection standards.

Who is required to file masimo announces ce marking?

Manufacturers of medical devices and technologies such as those produced by Masimo are required to file for CE marking to demonstrate compliance with European regulations.

How to fill out masimo announces ce marking?

To fill out the masimo announces CE marking, manufacturers must complete a technical documentation that outlines the product's design, intended use, compliance with applicable regulations, and risk assessments, followed by submission to a notified body for review.

What is the purpose of masimo announces ce marking?

The purpose of masimo announces CE marking is to ensure that medical devices meet the safety and regulatory standards set by the European Union, allowing them to be marketed and sold within EU member states.

What information must be reported on masimo announces ce marking?

Information that must be reported includes product specifications, user manuals, clinical evaluations, risk management files, and details on manufacturing processes.

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