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Disposable oral irrigator - NMPA Registration 豫械注准20232170017

Access comprehensive regulatory information for Disposable oral irrigator 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20232170017 and owned by Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.. The device was approved on January 13, 2023.

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20232170017
Disposable oral irrigator
一次性使用口腔冲洗器
NMPA Registration Number: 豫械注准20232170017
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Intended Use
English

Used to remove debris or debris from the mouth.

中文

用于去除口腔中的碎屑或杂物。

Device Classification
Device Class
Class II
Model Specifications
Type I (adjustable)
Ⅰ型(可调节型)
Approval Department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration Information
Registration Number
豫械注准20232170017
Approval Date
January 13, 2023
Expiry Date
January 12, 2028
Registrant
Name
Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.
河南省健琪医疗器械有限公司
Province/Region
Henan
河南
Address
Dingluan Industrial Zone, Changyuan City
长垣市丁栾工业区
Production Facility
Production Address
长垣市丁栾工业区
Structure and Composition
English

Disposable oral irrigators are mainly made of medical polymer materials, which are composed of cork trocar protective sleeve, cork puncture device, air filter, drop hopper and dropper, flow regulator and water pipe.

中文

一次性使用口腔冲洗器主要采用医用高分子材料制成;由瓶塞穿刺器保护套、瓶塞穿刺器、空气过滤器、滴斗与滴管、流量调节器、输水管组成。

Additional Information
Appendix
产品技术要求