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.
Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
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Guidance Document - Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs)
