6123028CE01
| EU Quality Management System Certificate Conformity Assessment Regulation 2017/745 on Medical devices, Annex IX Chapter I and III | |
| Manufacturer: | Anrei Medical (HZ) Co., Ltd. No. 3, Ave. 8, Hangzhou Economic Development Area 310018 Hangzhou, Zhejiang China SRN ID.: CN-MF-000009964 |
| device(s) / groups of device(s): | |
| Non-active non-implantable devices instruments (MDN1208, class Is) Sterilization method: EtO | |
| Device Name: - Single-use Cytology Brush - Single Use Biopsy Valve - Single Use Guidewire Lock Kit - Single Use Endoscope Valves Set - Single use Grasping Forceps GGF - Single use Grasping Forceps BGF - Single use Grasping Forceps UGF - Rescue single-Use Grasping forceps - Rescue Pulmonary grasping forceps - Single Use Retrieval Net - Single Use Foreign Body Forceps - VersaGrasp Single-Use Grasping Forceps | |
| Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis (MDN1202, class IIa) | |
| Device Name: - Sclerotherapy Needle | |
| Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools (MDN1203, class IIa) | |
| Group of Devices: - Single-use Balloon Dilatation Catheter | |
| Device Name: - Single-Use Stone Retrieval Balloon Catheter - Single-use Biliary Drainage Catheter - Single-use Urinary Guide Wire | |
| Status | Valid |