| 注册证编号 | 京械注准20172020787 [查看相关产品信息] |
| 注册人名称 | 北京派尔特医疗科技股份有限公司[查看公司信息] |
| 注册人住所 | 北京市昌平区北七家镇上承路8号 |
| 生产地址 | 北京市昌平区北七家镇上承路 8 号 A区、B区、C区,北京市昌平区科技园区火炬街28号,北京市朝阳区金盏大街西路白桥工业区西侧2号,北京市昌平区北七家镇亚市南路 C8 号 |
| 产品名称 | 一次性使用吻合器组合包 |
| 管理类别 | 第二类 |
| 型号规格 | WAE21ZN55WAE21ZN60WAE21ZN75WAE21ZN80WAE21ZN100WAE21ZN110WAE24ZN55WAE24ZN60WAE24ZN75WAE24ZN80WAE24ZN100WAE24ZN110WAE26ZN55WAE26ZN60WAE26ZN75WAE26ZN80WAE26ZN100WAE26ZN110WAE28ZN55WAE28ZN60WAE28ZN75WAE28ZN80WAE28ZN100WAE28ZN110WAE29ZN55WAE29ZN60WAE29ZN75WAE29ZN80WAE29ZN100WAE29ZN110WAE32ZN55WAE32ZN60WAE32ZN75WAE32ZN80WAE32ZN100WAE32ZN110WAE34ZN55WAE34ZN60WAE34ZN75WAE34ZN80WAE34ZN100WAE34ZN110WAE21ZO55WAE21ZO60WAE21ZO75WAE21ZO80WAE21ZO100WAE21ZO110WAE24ZO55WAE24ZO60WAE24ZO75WAE24ZO80WAE24ZO100WAE24ZO110WAE26ZO55WAE26ZO60WAE26ZO75WAE26ZO80WAE26ZO100WAE26ZO110WAE28ZO55WAE28ZO60WAE28ZO75WAE28ZO80WAE28ZO100WAE28ZO110WAE29ZO55WAE29ZO60WAE29ZO75WAE29ZO80WAE29ZO100WAE29ZO110WAE32ZO55WAE32ZO60WAE32ZO75WAE32ZO80WAE32ZO100WAE32ZO110WAE34ZO55WAE34ZO60WAE34ZO75WAE34ZO80WAE34ZO100WAE34ZO110WBE21ZN55WBE21ZN60WBE21ZN75WBE21ZN80WBE21ZN100WBE21ZN110WBE24ZN55WBE24ZN60WBE24ZN75WBE24ZN80WBE24ZN100WBE24ZN110WBE26ZN55WBE26ZN60WBE26ZN75WBE26ZN80WBE26ZN100WBE26ZN110WBE28ZN55WBE28ZN60WBE28ZN75WBE28ZN80WBE28ZN100WBE28ZN110WBE29ZN55WBE29ZN60WBE29ZN75WBE29ZN80WBE29ZN100WBE29ZN110WBE32ZN55WBE32ZN60WBE32ZN75WBE32ZN80WBE32ZN100WBE32ZN110WBE34ZN55WBE34ZN60WBE34ZN75WBE34ZN80WBE34ZN100WBE34ZN110WBE21ZO55WBE21ZO60WBE21ZO75WBE21ZO80WBE21ZO100WBE21ZO110WBE24ZO55WBE24ZO60WBE24ZO75WBE24ZO80WBE24ZO100WBE24ZO110WBE26ZO55WBE26ZO60WBE26ZO75WBE26ZO80WBE26ZO100WBE26ZO110WBE28ZO55WBE28ZO60WBE28ZO75WBE28ZO80WBE28ZO100WBE28ZO110WBE29ZO55WBE29ZO60WBE29ZO75WBE29ZO80WBE29ZO100WBE29ZO110WBE32ZO55WBE32ZO60WBE32ZO75WBE32ZO80WBE32ZO100WBE32ZO110WBE34ZO55WBE34ZO60WBE34ZO75WBE34ZO80WBE34ZO100WBE34ZO110WCE21ZN55WCE21ZN60WCE21ZN75WCE21ZN80WCE21ZN100WCE21ZN110WCE24ZN55WCE24ZN60WCE24ZN75WCE24ZN80WCE24ZN100WCE24ZN110WCE25ZN55WCE25ZN60WCE25ZN75WCE25ZN80WCE25ZN100WCE25ZN110WCE26ZN55WCE26ZN60WCE26ZN75WCE26ZN80WCE26ZN100WCE26ZN110WCE28ZN55WCE28ZN60WCE28ZN75WCE28ZN80WCE28ZN100WCE28ZN110WCE29ZN55WCE29ZN60WCE29ZN75WCE29ZN80WCE29ZN100WCE29ZN110WCE32ZN55WCE32ZN60WCE32ZN75WCE32ZN80WCE32ZN100WCE32ZN110WCE34ZN55WCE34ZN60WCE34ZN75WCE34ZN80WCE34ZN100WCE34ZN110WCE21ZO55WCE21ZO60WCE21ZO75WCE21ZO80WCE21ZO100WCE21ZO110WCE24ZO55WCE24ZO60WCE24ZO75WCE24ZO80WCE24ZO100WCE24ZO110WCE25ZO55WCE25ZO60WCE25ZO75WCE25ZO80WCE25ZO100WCE25ZO110WCE26ZO55WCE26ZO60WCE26ZO75WCE26ZO80WCE26ZO100WCE26ZO110WCE28ZO55WCE28ZO60WCE28ZO75WCE28ZO80WCE28ZO100WCE28ZO110WCE29ZO55WCE29ZO60WCE29ZO75WCE29ZO80WCE29ZO100WCE29ZO110WCE32ZO55WCE32ZO60WCE32ZO75WCE32ZO80WCE32ZO100WCE32ZO110WCE34ZO55WCE34ZO60WCE34ZO75WCE34ZO80WCE34ZO100WCE34ZO110 |
| 结构及组成/主要组成成分 | 一次性使用吻合器组合包产品是将已取得注册证书的管型吻合器（FCSLE系列）、一次性使用管型吻合器及组件（FCSME系列）产品及一次性使用直线型切割吻合器系列产品组合而成。 |
| 适用范围/预期用途 | 适用于胃、肺等组织和消化道手术吻合用。 |
| 审批部门 | 北京市药品监督管理局 |
| 批准日期 | 2022/1/20 |
| 生效日期 | 2022/1/20 |
| 有效期至 | 2027/7/23 |
