Low-risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746
X
EU_CLASS_B
Low-medium risk In-Vitro Diagnostics
Low-Medium risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746
X
EU_CLASS_C
Medium-high risk In-Vitro Diagnostics
Medium-high as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746
X
EU_CLASS_D
High-risk In-Vitro Diagnostics
High-risk as specified in the final European In vitro Diagnostic Device Regulation (EU) 2017/746
X
EU_CLASS_I
Low-risk Medical Device
Low-risk as specified in the final European Medical Device Regulation (EU) 2017/745
X
EU_CLASS_IIA
Low-medium risk Medical Device
Low-Medium risk as specified in the final European Medical Device Regulation (EU) 2017/745
X
EU_CLASS_IIB
Medium-high risk Medical Device
Medium-high risk as specified in the final European Medical Device Regulation (EU) 2017/745
X
EU_CLASS_III
High-risk Medical Device
High-risk as specified in the final European Medical Device Regulation (EU) 2017/745
X
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