China NMPA legacy archive 鲁械注准20242180862Disposable cervical dilatation balloon catheter
- Device class
- Class II
- Model specifications
- 18Fr.
- Approval department
- Shandong Provincial Drug Administration
- Registration number
- 鲁械注准20242180862
- Approval date
- September 05, 2024
- Expiry date
- September 04, 2029
- Province/Region
- Shandong
- Address
- No. 1, Weigao Road, Weihai Torch High-tech Industrial Development Zone, Shandong Province
- 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
This static archive preserves historical registration fields and translations for Disposable cervical dilatation balloon catheter, registration 鲁械注准20242180862. It does not establish current authorization or complete current product details.
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