High Frequency Surgical Equipment Has Generator And Surgical Accessories, Are They Able To Submit Registration Separately? If Separately Registered, Do They Have To Clarify The Matching Situation?

The generator and surgical accessories of high frequency surgical equipment can either be submitted registration as the whole product, or separately.

High frequency surgical equipment used for normal cutting and coagulation is generally considered as commonly universality. If they are submitted separately, the matching situation does not need to be clarified.

The high frequency generator shall clarify its connection port and the rated power, maximum output voltage, and crest factor of each output mode. The high frequency surgical instrument shall clarify its connection port and the maximum rated accessory voltage. If the connection port and parameters from two sides match, they will be able to use together.

For unconventionality used cutting and coagulation function of the high frequency generator and accessories, the matching situation shall be clarified.