| 证明类型: | 医疗器械出口销售证明(Ι) |
|---|---|
| 证书编号: | 京药监械出2026000117号 |
| Certificate No.: | No.MDBJ2026000117 |
| 产品名称: | 钴基合金生物可降解涂层雷帕霉素洗脱支架系统,生物可吸收冠状动脉雷帕霉素洗脱支架系统,血管内无载体含药 (雷帕霉素) 洗脱支架系统,血管内药物 (雷帕霉素) 洗脱支架系统 |
| Product Name: | GuReater PLUS CoCr Sirolimus-eluting Coronary Stent System,NeoVas Bioabsorbable Sirolimus-Eluting Stent System,Nano+TM Polymer-free Sirolimus-eluting Coronary Stent System,Partner? Sirolimus-eluting Coronary Stent System |
| 规格型号: | |
| Model and Specification: | |
| 产品注册或备案凭证号: | 国械注准20263130521,国械注准20193130093,国械注准20153131361,国械注准20163131475 |
| Medical Device Registration No./Medical Device Filing No.: | See Annex |
| 生产企业: | 乐普(北京)医疗器械股份有限公司 |
| Medical Device Manufacturer: | Lepu Medical Technology (Beijing) Co., Ltd. |
| 生产企业住所: | 北京市昌平区超前路37号 |
| Domicile: | No.37 Chaoqian Road, Changping District, Beijing, 102200, China. |
| 生产地址: | 北京市昌平科技园区超前路37号3号楼; 北京市昌平科技园区超前路37号7-1号楼 |
| Manufacturing Address: | Building 3, No.37 Chaoqian Road, Changping District, Beijing, 102200, China; Building 7-1, No.37 Chaoqian Road, Changping District, Beijing, 102200, China. |
| 生产许可或备案凭证号: | 京药监械生产许20000182号 |
| Medical Device Manufacturing License No./Manufacturing Filing No.: | |
| 有效日期至: | 2029-02-21 |
| This Certificate Remains Valid Until: | 02/21/2029 |
| 出具日期: | 2026-06-01 |
| 备注: | |
| Remark: | |
| 附页: | |
| 附件: | |
| Annex: |