2141980CE01
| Company | Shanghai MicroPort Medical (Group) Co., Ltd. | |||
| Address | 501 Newton Road ZJ Hi-Tech Park 201203 Shanghai PEOPLE’S REPUBLIC OF CHINA | |||
| Regulation | Full Quality Assurance System Directive 93/42/EEC on Medical devices, Annex II excluding (4) | |||
| Product | Medical Devices for Cardiovascular Interventional and Surgical Procedures This certificate covers the following product(s): | |||
| Balloon Catheters: • PTCA Balloon Catheters (Firefighter, Firefighter NC) (Class III) • PTCA Balloon Catheters (Foxtrot NC, Foxtrot PRO) (Class III) | ||||
| Coronary Stent Systems: • CoCr Stents (WALTZ) (Class III) | ||||
| Rapamycin Eluting Coronary Stent Systems: • FirehawkTM Rapamycin Target Eluting Coronary Stent System (Class III) • Firehawk LibertyTM Rapamycin Target Eluting Coronary Stent System (Class III) | ||||
| Status | Valid | |||