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e) a descr
2023-09-14T04:56:32
Accredited Consultants Pvt Ltd
e) a description of the accessories, other medical device and other product that are not medical device, which

e) a description of the accessories, other medical device and other product that are not medical device, which are intended to be used in combination with it and it should also be clarified whether these accessories or device are supplied as a system or separate components; (f) a description or complete list of the various configurations or variants of the device that will be made available; (g) a general description of the key functional elements, e.g. its parts or components (including software if appropriate), its formulation, its composition, its functionality and where appropriate, this will include: labeled pictorial representations (e.g. diagrams, photographs, and drawings), clearly indicating key parts or components, including sufficient explanation to understand the drawings and diagrams; (h) a description of the materials incorporated into key functional elements and those making either direct contact with a human body or indirect contact with the body, e.g., during extracorporeal circulation of body fluids. Complete chemical, biological and physical characterization of the material(s) of the medical device;

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