Class II medical devices have moderate to higher risks to patients or users. Over 40% of medical devices fall into this device category. The majority of medical devices are considered to be Class II devices. Some examples of Class II devices include catheters, syringes, contact lens, and pregnancy test kits.
A guide to FDA regulations for medical devices - Spyrosoft
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Interoperability standards for medical device integration in the OR and issues relating to international approval procedures (part 4) - ISCASBlog
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Medical Device Classification Guide - How To Determine Your Device Class
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What's the Difference between a Class I Medical Device and a Class II?
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