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Disposable cervical dilatation balloon catheter - NMPA Registration 鲁械注准20242180862

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.

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Class II
鲁械注准20242180862
Disposable cervical dilatation balloon catheter
一次性使用子宫颈扩张球囊导管
NMPA Registration Number: 鲁械注准20242180862
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Intended Use
English

Used for mechanical dilation of the cervical canal in poorly mature cervix prior to term induction of labour.

中文

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。

Device Classification
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 Information
Registration Number
鲁械注准20242180862
Approval Date
September 05, 2024
Expiry Date
September 04, 2029
Registrant
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 Facility
Production Address
山东省威海火炬高技术产业开发区威高路1-1号
Structure and Composition
English

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.

中文

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。

Additional Information
Appendix
产品技术要求