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CATEGORY: CLASSIFICATION
Class IIb (EU MDR)
A medium-high risk device class under EU MDR. Class IIb devices require more extensive Notified Body review. Examples include ventilators, bone fixation plates, and blood bags.
A medium-high risk device class under EU MDR. Class IIb devices require more extensive Notified Body review. Examples include ventilators, bone fixation plates, and blood bags.