Disposable cervical dilatation balloon catheter
- Device class
- Class II
- Model specifications
- 18Fr.18Fr。
- Approval department
- Shandong Provincial Drug Administration山东省药品监督管理局
- Registration number
- 鲁械注准20242180862
- Approval date
- September 05, 2024
- Expiry date
- September 04, 2029
- Name
- Shandong Weigao Group MEDICAL Polymer Co., Ltd.山东威高集团医用高分子制品股份有限公司
- Province/Region
- Shandong山东
- Address
- No. 1, Weigao Road, Weihai Torch High-tech Industrial Development Zone, Shandong Province山东省威海火炬高技术产业开发区威高路1号
- Production address
- 山东省威海火炬高技术产业开发区威高路1-1号
Used for mechanical dilation of the cervical canal in poorly mature cervix prior to term induction of labour.
用于足月引产前对成熟度不佳的宫颈进行宫颈管的机械扩张。
The product consists of a balloon cervical dilator and a support rod, where the balloon cervical dilator is composed of a catheter tip, a uterine balloon, a vaginal balloon, a catheter body, a joint, a ferrule and a one-way valve.
产品由球囊宫颈扩张器和支撑杆组成，其中球囊宫颈扩张器由导管头端、子宫球囊、阴道球囊、导管管体、接头、卡套和单向阀组成。
- Appendix
- 产品技术要求
Access comprehensive regulatory information for Disposable cervical dilatation balloon catheter in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242180862 and owned by Shandong Weigao Group MEDICAL Polymer Co., Ltd.. The device was approved on September 05, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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.