6124696CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
| Manufacturer: | Zhejiang Medstar Technology Co., Ltd. No.2759 Guangyi Road, Daqiao Town, Nanhu District 314006 Jiaxing, Zhejiang China SRN ID.: CN-MF-000028154 |
| Mono- and bipolar surgical instruments, single-use (K020101, class IIb) | |
| Group of Devices: Open-surgery electrosurgical handpieces / electrodes with smoke evacuation function | Intended Purpose: Open-surgery electrosurgical handpieces / electrodes enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for soft tissue cutting and coagulation. Open-surgery electrosurgical handpieces / electrodes with smoke evacuation function remove smoke plume from the surgical site, when used with an effective smoke evacuation system. |
| Group of Devices: Open-surgery electrosurgical handpieces / electrodes without smoke evacuation function | Intended Purpose: The device enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for soft tissue cutting and coagulation. |
| Group of Devices: Laparoscopic electrosurgical handpieces / electrodes | Intended Purpose: Laparoscopic electrosurgical handpieces / electrodes are intended for grasping, cutting, dissecting, retracting, clamping, cauterizing, and/or suction/irrigation in conjunction with a laparoscope during Laparoscopic surgery. |