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Medical Device Application Technical Files such as device description, intended purpose, design and manufacturing details, labeling, risk assessment, and clinical evidence (if required) Australian Declaration of Conformity Manufacturers Evidence (CE Certificate) Appointment of Australian Sponsor Pre-Market Evaluation For higher-risk device classes such as Class IIb and III, a pre-market evaluation may be required

At advanced stages, ion accumulation (especially Na + and Cl ) changes the relationship between cotransporters with their ligands: increased ratios of intracellular Na + /K + and probably also, to a lesser extent, decreased ratios for Na + coupled Ca 2+ transport result in enhanced ROS production

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