There are many cases of combination products in activemedical devices.One product contains two independent functionalmodules, and each module belongs to a different classificationcategory and code.In this case, the classification level should bemanaged according to the higher one of the two categories.For the classification codes,if there is already clearly classifiedannouncement,it shall prevail. If not,administrative counterpartsmay justify which module of the product is the major one and use thecategory and code of this module. If manufacture cannot justify, theneither one can be used when submitting and no separate classificationrequest is not needed.

For instance of the Integrated Surgical Equipment of Ultrasoundand High Frequency, the category code of Ultrasound SurgicalEquipment is 01-01-01 and the High Frequency Surgical Equipmentis 01-03-01, both of which are class [l device under 01 categoryso the whole device is also class Il.If the main function is theultrasound surgical, then the application category code should be 01-01-01.