Bipolar radiofrequency surgical scalpel head belongs to which class of medical devices?

Hello, bipolar radiofrequency scalpel head belongs to the import of Class III medical devices, structure and composition: the product consists of electrode tube, handle, wire, plug, plug inner membrane, wire sheath, O-ring seal, spring, adhesive composition. The products are single-use, ethylene oxide sterilized, valid for 3 years.

The registration process of Class III imported medical devices need to submit the following information:

(1) application form for registration of overseas medical devices

(2) proof of qualification of the medical device manufacturer

(3) copy of the business license of the declarant and the letter of attorney granted by the manufacturer to act as an agent for the registration of

(4) approval of the competent authority of the overseas government for medical device or recognized by the overseas government medical device authorities to enter the country (region) as a medical device market documents

(5) applicable product standards

(6) medical device instructions

(7) medical device testing organizations issued by the product registration test report (such as the product is a class of not required)

(8) medical device clinical trials (Class III implantable products for the first time into China and the manufacturer of such products) Class I products into China for the first time and the manufacturer does not have other products have been SFDA registration; as well as not obtained foreign marketing approval of Class II, III products need to be in China for clinical trials)