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Re DECLARATION OF CONFORMITY Class B Device We, PHILIPS CONSUMER ELECTRONICS B. J;: EINDHOVEN (Manufacturer's Representative) P.O. BOX 80002, 5600 JB EINDHOVEN, NETHERLANDS (Representative's address)
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Class B device is a category of medical devices that have a moderate to high risk and require pre-market approval from regulatory authorities before being marketed or distributed.
Manufacturers of medical devices falling under the Class B category are required to file the necessary documentation for pre-market approval.
To fill out a Class B device application, manufacturers must provide detailed information on the device's design, intended use, clinical data, risk assessment, and quality control processes.
The purpose of Class B device classification is to ensure the safety and efficacy of medical devices with moderate to high risk levels before they are made available for public use.
Information such as device specifications, intended use, clinical data, risk assessment, quality control processes, and post-market surveillance plans must be reported for Class B devices.
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