| 注册证编号 | 赣械注准20242010067 [查看相关产品信息] |
| 注册人名称 | 南昌华安众辉健康科技股份有限公司[查看公司信息] |
| 注册人住所 | 江西省南昌市南昌高新技术产业开发区创新一路59号5号楼 |
| 生产地址 | 江西省南昌市南昌高新技术产业开发区创新一路59号5号楼 |
| 产品名称 | 一次性使用解剖器 |
| 管理类别 | 第二类 |
| 型号规格 | RH5-01-01、RH5-01-02、RH5-01-03、RH5-01-11、RH5-01-12、RH5-01-13、RH5-02-01、RH5-02-02、RH5-02-03、RH5-02-11、RH5-02-12、RH5-02-13、RH5-11-01、RH5-11-02、RH5-11-03、RH5-11-11、RH5-11-12、RH5-11-13、RH5-12-01、RH5-12-02、RH5-12-03、RH5-12-11、RH5-12-12、RH5-12-13、RH5-13-01、RH5-13-02、RH5-13-03、RH5-13-11、RH5-13-12、RH5-13-13、RH5-21-01、RH5-21-02、RH5-21-03、RH5-21-11、RH5-21-12、RH5-21-13、RH5-22-01、RH5-22-02、RH5-22-03、RH5-22-11、RH5-22-12、RH5-22-13、RH5-23-01、RH5-23-02、RH5-23-03、RH5-23-11、RH5-23-12、RH5-23-13、RH5-24-01、RH5-24-02、RH5-24-03、RH5-24-11、RH5-24-12、RH5-24-13、RH5-31-01、RH5-31-02、RH5-31-03、RH5-31-11、RH5-31-12、RH5-31-13、RH5-32-01、RH5-32-02、RH5-32-03、RH5-32-11、RH5-32-12、RH5-32-13、RH5-41-01、RH5-41-02、RH5-41-03、RH5-41-11、RH5-41-12、RH5-41-13、RH5-42-01、RH5-42-02、RH5-42-03、RH5-42-11、RH5-42-12、RH5-42-13、RH5-43-01、RH5-43-02、RH5-43-03、RH5-43-11、RH5-43-12、RH5-43-13、RH5-44-01、RH5-44-02、RH5-44-03、RH5-44-11、RH5-44-12、RH5-44-13、RH5-45-01、RH5-45-02、RH5-45-03、RH5-45-11、RH5-45-12、RH5-45-13、RH5-46-03、RH5-46-04、RH5-46-05、RH5-46-13、RH5-46-14、RH5-46-15、RH5-51-01、RH5-51-02、RH5-51-03、RH5-51-11、RH5-51-12、RH5-51-13、RH5-52-03、RH5-52-04、RH5-52-05、RH5-52-13、RH5-52-14、RH5-52-15、RH5-61-03、RH5-61-04、RH5-61-05、RH5-61-13、RH5-61-14、RH5-61-15、RH5-71-03、RH5-71-04、RH5-71-05、RH5-71-13、RH5-71-14、RH5-71-15、RH5-72-03、RH5-72-04、RH5-72-05、RH5-72-13、RH5-72-14、RH5-72-15、RH5-81-01、RH5-81-02、RH5-81-03、RH5-81-11、RH5-81-12、RH5-81-13、RH5-82-01、RH5-82-02、RH5-82-03、RH5-82-11、RH5-82-12、RH5-82-13、RH5-83-03、RH5-83-04、RH5-83-05、RH5-83-13、RH5-83-14、RH5-83-15、RH5-91-03、RH5-91-04、RH5-91-05、RH5-91-13、RH5-91-14、RH5-91-15、RH5-92-01、RH5-92-02、RH5-92-03、RH5-92-11、RH5-92-12、RH5-92-13、RH5-93-01、RH5-93-02、RH5-93-03、RH5-93-11、RH5-93-12、RH5-93-13、RH5-94-03、RH5-94-04、RH5-94-05、RH5-94-13、RH5-94-14、RH5-94-15 |
| 结构及组成/主要组成成分 | 产品主要由电极刀头、手柄、电缆线、插头组成，可选配保护套、滴水管、流量调节阀、吸引管、LED灯、疏通棒、清洁片。RH5-01型、RH5-02型、RH5-52型、RH5-83型为可拔插电极刀头，根据用户需求同时配置多种电极。产品初包装采用吸塑盒或纸塑袋包装，经环氧乙烷灭菌，产品无菌。 |
| 适用范围/预期用途 | 作为手术设备附件，与高频发生器和/或射频发生器配合使用，或与吸引装置配套使用。供临床普通外科手术、耳鼻喉科手术、心胸外科手术、神经外科手术、骨科手术、甲乳外科手术、小儿外科手术、妇科手术、口腔科手术等各类外科手术中皮肤、皮下组织、肌肉(括约肌)、肿瘤、各类软组织的电凝、切割、消融及止血、吸引的应用。 |
| 审批部门 | 江西省药品监督管理局 |
| 批准日期 | 2024/4/16 |
| 生效日期 | 2024/4/16 |
| 有效期至 | 2029/4/15 |
