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Single-use drainage kit - NMPA Registration 鲁械注准20242140812

Access comprehensive regulatory information for Single-use drainage kit 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20242140812 and owned by Shandong Weigao Group MEDICAL Polymer Co., Ltd.. The device was approved on August 20, 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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NMPA Official Data
Class II
鲁械注准20242140812
Single-use drainage kit
一次性使用引流套装
NMPA Registration Number: 鲁械注准20242140812
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Intended Use
English

For donor surface trauma or incision drainage.

中文

供体表创伤或切口引流用。

Device Classification
Device Class
Class II
Model Specifications
See annex.
见附件。
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242140812
Approval Date
August 20, 2024
Expiry Date
August 19, 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 Type I drainage kit consists of a drain and a puncture. The Type II drainage kit consists of a drain, a trocar and a drainage ball. The Type III drainage kit consists of a drainage tube, a puncture device, and a drainage bag. The Type IV drainage kit consists of a drainage tube, a trocar, a drainage ball and a drainage bag.

中文

I型引流套装为引流管和穿刺器组成。II型引流套装为引流管、穿刺器和引流球组成。III型引流套装为引流管、穿刺器和引流袋组成。IV型引流套装为引流管、穿刺器、引流球和引流袋组成。

Additional Information
Appendix
产品技术要求