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Disposable super smooth catheterization bag - NMPA Registration 鲁械注准20242140919

Access comprehensive regulatory information for Disposable super smooth catheterization bag 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20242140919 and owned by Shandong Weigao Group MEDICAL Polymer Co., Ltd.. The device was approved on October 14, 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20242140919
Disposable super smooth catheterization bag
一次性使用超滑导尿包
NMPA Registration Number: 鲁械注准20242140919
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Intended Use
English

It is suitable for urination in patients with urinary occlusion and urinary retention and catheterization for preoperative and postoperative patients.

中文

适用于尿闭、尿潴留患者排尿和术前、术后病人导尿用。

Device Classification
Device Class
Class II
Model Specifications
See the attached table for specifications and models
见规格型号附表
Approval Department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration Information
Registration Number
鲁械注准20242140919
Approval Date
October 14, 2024
Expiry Date
October 13, 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1-5号(委托生产)
Structure and Composition
English

The structure of the catheterization kit consists of a basic configuration and an optional configuration. The basic configuration is a urinary catheter, and the selection is a guidewire, a drainage bag, a disposable sterile drug-dissolving syringe, a water bag, a forceps, a disposable sterile drug-dissolving needle, a disposable sterilized rubber surgical glove, a disposable medical rubber examination glove, gauze, a cotton ball, a square towel, a hole towel, an operating tablecloth, a tray, a fixing pin, a plastic clip, an alcohol cotton ball, an iodophor cotton ball, a balloon fixative solution, a test tube, a rubber stopper, a leather knife, a dressing clip, a catheter fixation sticker, and a urinary tube label.

中文

导尿包的结构由基本配置和选用配置组成。基本配置为导尿管,选用配置为导丝、引流袋、一次性使用无菌溶药注射器、水包、镊子、一次性使用无菌溶药针、一次性使用灭菌橡胶外科手套、一次性使用医用橡胶检查手套、纱布、棉球、方巾、洞巾、操作台布、托盘、固定别针、塑料夹子、酒精棉球、碘伏棉球、球囊固定液、试管、胶塞、备皮刀、敷料夹、导管固定贴、尿管标签。

Additional Information
Remark
受托生产企业名称:山东威高瑞新医疗技术有限公司 统一社会信用代码:91371000MA7L9Y1Y5M
Appendix
产品技术要求