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Disposable Hemodialysis Circuit - NMPA Registration 国械注准20243101823

Access comprehensive regulatory information for Disposable Hemodialysis Circuit in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243101823 and owned by Jiangxi HONGDA MEDICAL Equipment Group Ltd.. The device was approved on September 19, 2024.

This page provides complete registration details including registrant information, province location (Jiangxi), 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 III
国械注准20243101823
Disposable Hemodialysis Circuit
一次性使用血液透析管路
NMPA Registration Number: 国械注准20243101823
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Pricing
Intended Use
English

This product is intended for hemodialysis to establish blood channels.

中文

本产品供血液透析建立血液通道使用。

Device Classification
Device Class
Class III
Model Specifications
NP20-A、NP20-B、NP22-A、NP22-B、NP30-A、NP30-B
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243101823
Approval Date
September 19, 2024
Expiry Date
September 18, 2029
Registrant
Name
Jiangxi HONGDA MEDICAL Equipment Group Ltd.
江西洪达医疗器械集团有限公司
Province/Region
Jiangxi
江西
Address
No. 39, Shengli South Road, Jinxian County, Nanchang City, Jiangxi Province
江西省南昌市进贤县城胜利南路39号
Production Facility
Production Address
江西省南昌市进贤县城胜利南路39号
Structure and Composition
English

Disposable hemodialysis tubing route protection cap, irrigation joint, rotary joint, main water stop clip, main pipe, sampling port, T-tee, auxiliary pipe water stop, auxiliary pipeline, auxiliary pipeline joint, pump pipe, pump pipe joint, anticoagulant tubing, anticoagulant tubing joint, arterial pot cover, arterial pot, dialyzer joint, dialyzer joint protective cap, blood filter, venous pot, venous pot cover, pressure sensor tubing, pressure sensor tubing fitting, sensor protector, puncture protector, puncture protector, air filtration membrane, It consists of an air inlet plug, a drip bucket, a flushing line, a flow regulator, a cone joint, a protective sleeve, a bag and a hose. Among them, T-type tee, drip bucket and flow regulator are optional accessories. The product is sterilized by ethylene oxide and is single-use.

中文

一次性使用血液透析管路由保护帽、冲洗接头、旋转接头、主管止水夹、主管路、采样口、T型三通、辅管止水夹、辅助管路、辅助管路接头、泵管、泵管接头、抗凝剂管路、抗凝剂管路接头、动脉壶盖、动脉壶、透析器接头、透析器接头保护帽、血液过滤器、静脉壶、静脉壶盖、压力传感器管路、压力传感器管路接头、传感器保护器、穿刺器保护套、穿刺器、空气过滤膜、进气塞、滴斗、冲洗管路、流量调节器、圆锥接头、保护套、袋体、软管组成。其中T型三通、滴斗、流量调节器为可选配件。产品经环氧乙烷灭菌,一次性使用。

Additional Information
Appendix
产品技术要求