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Full chest oscillation sputum suction machine - NMPA Registration 豫械注准20242090786

Access comprehensive regulatory information for Full chest oscillation sputum suction machine in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 豫械注准20242090786 and owned by XiangyuMedicalCo.,Ltd.. The device was approved on September 30, 2024.

This page provides complete registration details including registrant information, province location (Henan), 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
豫械注准20242090786
Full chest oscillation sputum suction machine
全胸振荡排痰机
NMPA Registration Number: 豫械注准20242090786
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Intended Use
English

Expectoration is used for airway clearance therapy in external thoracic disposition, for patients with difficulty in excretion of secretions or pulmonary insufficiency due to mucus obstruction, and at the same time, to promote airway clearance or improve bronchial drainage, and to collect mucus for diagnostic evaluation; The nebulization function provides a driving source for the atomization of liquid drugs; The negative pressure sputum suction function is used by the hospital for sputum suction for patients.

中文

排痰功能用于胸腔外部处置时进行气道清除治疗,适用于分泌物排出困难或由粘液阻塞引起的肺膨胀不全患者,同时,促进气道清除或改善支气管引流,为诊断评估收集粘液;雾化功能为液态药物雾化提供驱动源;负压吸痰功能供医院为病人作吸痰用。

Device Classification
Device Class
Class II
Model Specifications
XY-K-PTJ-I、XY-K-PTJ-II、XY-K-PTJ-V
Approval Department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration Information
Registration Number
豫械注准20242090786
Approval Date
September 30, 2024
Expiry Date
September 29, 2029
Registrant
Name
XiangyuMedicalCo.,Ltd.
河南翔宇医疗设备股份有限公司
Province/Region
Henan
河南
Address
The middle section of Di Zhe Avenue in Huang County, Anyang City, Henan Province
河南省安阳市内黄县帝喾大道中段
Production Facility
Production Address
河南省安阳市内黄县帝喾大道中段
Structure and Composition
English

The full-chest oscillating expectoration machine is composed of a host, a trachea hose, an inflatable air bag, a handheld controller, an atomization drive module (XY-K-PTJ-V), a sputum suction assembly (XY-K-PTJ-V), and a foot switch (XY-K-PTJ-V).

中文

全胸振荡排痰机由主机、导气软管、充气气囊、手持控制器、雾化驱动模块(XY-K-PTJ-V具有)、吸痰组件(XY-K-PTJ-V具有)、脚踏开关(XY-K-PTJ-V具有)组成。

Additional Information
Appendix
产品技术要求