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KimberlyClark B.V. Copernicuslaan 35, 6716 BM Ede, NetherlandsManufacturer DeclarationDATE: 29th November 2024The manufacturer hereby declares that in accordance with Annex I, provision 23.1 of the
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What is medical device declaration of?
The medical device declaration is a formal statement that verifies the compliance of a medical device with regulatory requirements. It outlines the specifics of the device, its intended use, and its safety and performance standards.
Who is required to file medical device declaration of?
Manufacturers, importers, and distributors of medical devices are typically required to file a medical device declaration to ensure that their products meet the necessary regulatory standards.
How to fill out medical device declaration of?
To fill out a medical device declaration, gather all necessary information about the device, ensure compliance with applicable regulations, and complete the designated form accurately, providing all required details about the device's specifications, intended use, and manufacturer information.
What is the purpose of medical device declaration of?
The purpose of the medical device declaration is to provide assurance that the device meets safety and efficacy standards, protects public health, and complies with legal and regulatory requirements.
What information must be reported on medical device declaration of?
The information that must be reported includes the device's identification details, manufacturer information, intended use, compliance with relevant standards, and any applicable test results or certifications.
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