一次性使用腹腔镜持针器
- Device class
- Class II
- Model specifications
- LN-285-Z、LN-345-Z、LN-405-Z
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242020510
- Approval date
- September 30, 2024
- Expiry date
- September 29, 2029
- Name
- B.J.Zh.F.Panther Medical Equipment Co., Ltd.北京派尔特医疗科技股份有限公司
- Province/Region
- Beijing北京
- Address
- The third floor of Building 1, No. 28 Torch Street, Science and Technology Park, Changping District, Beijing北京市昌平区科技园区火炬街28号1号楼三层
- Production address
- 北京市昌平区北七家镇上承路8号A区、B区、C区;北京市昌平区北七
产品与腹腔镜配合,供腹腔手术中用于夹持缝合针、缝合线,用于缝合组织.
产品与腹腔镜配合，供腹腔手术中用于夹持缝合针、缝合线，用于缝合组织。
产品由头部、杆部和手柄组成,手柄包括基座、手环扣、传动带、拨轮、握柄、扳机、手环.产品为一次性使用,无菌提供,环氧乙烷灭菌,有效期5年.
产品由头部、杆部和手柄组成，手柄包括基座、手环扣、传动带、拨轮、握柄、扳机、手环。产品为一次性使用，无菌提供，环氧乙烷灭菌，有效期5年。
5 years
5年
- Changes
- 注册地址变更为：北京市昌平区科技园区火炬街28号1号楼三层。生产地址变更为：北京市昌平区北七家镇上承路8号A区、B区、C区;北京市昌平区北七。签发日期变更为：2024-09-30。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for 一次性使用腹腔镜持针器 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242020510 and owned by B.J.Zh.F.Panther Medical Equipment Co., Ltd.. The device was approved on September 30, 2024.
This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.