Pure Global

Disposable negative pressure drainage and wound protection materials - NMPA Registration 国械注准20253140286

Access comprehensive regulatory information for Disposable negative pressure drainage and wound protection materials 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20253140286 and owned by Shenzhen Lifotronic Technology Co., Ltd.. The device was approved on January 26, 2025.

This page provides complete registration details including registrant information, province location (Guangdong), 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.

Free Database
Powered by Pure Global AI
NMPA Official Data
Class III
国械注准20253140286
Disposable negative pressure drainage and wound protection materials
一次性使用负压引流护创材料
NMPA Registration Number: 国械注准20253140286
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Intended Use
English

本产品适用于负压封闭引流操作,适用于皮肤、软组织创面。包括:急性创伤、慢性创面。

Device Classification
Device Class
Class III
Model Specifications
S系列:NPWT-S-100A、NPWT-S-100D、NPWT-S-150A、NPWT-S-180A、NPWT-S-260A、NPWT-S-150C、NPWT-S-180C、NPWT-S-260C 。D系列:NPWT-D-100A、NPWT-D-150A、NPWT-D-180A、NPWT-D-260A、NPWT-D-150C、NPWT-D-180C、NPWT-D-260C 。T系列:NPWT-T-100A、NPWT-T-150A、NPWT-T-180A、NPWT-T-260A、NPWT-T-150C、NPWT-T-180C、NPWT-T-260C 。I系列:NPWT-I-100D。
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20253140286
Approval Date
January 26, 2025
Expiry Date
January 25, 2030
Registrant
Name
Shenzhen Lifotronic Technology Co., Ltd.
深圳普门科技股份有限公司
Province/Region
Guangdong
广东
Address
Pumen Science and Technology Headquarters Building, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua District, Shenzhen
深圳市龙华区观湖街道观城社区求知东路8号普门科技总部大厦
Production Facility
Production Address
广东省东莞市松山湖园区彰化路2号1号厂房4-9楼、11楼
Structure and Composition
English

由聚氨酯海棉、医用贴膜、引流管路(含止液夹)、三通连接管、Y型三通、直通、伤口尺组成。产品经伽马射线灭菌,无菌提供,一次性使用。

Additional Information
Appendix
产品技术要求