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Medical protective masks - NMPA Registration 豫械注准20182140825

Access comprehensive regulatory information for Medical protective masks 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20182140825 and owned by SHENGGUANG MEDICAL Instrument Co., Ltd.. The device was approved on October 18, 2022.

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20182140825
Medical protective masks
医用防护口罩
NMPA Registration Number: 豫械注准20182140825
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Intended Use
English

It is used in the medical work environment to filter particles in the air, block droplets, blood, body fluids, and secretions.

中文

供医疗工作环境下,过滤空气中的颗粒物、阻隔飞沫、血液、体液、分泌物用。

Device Classification
Device Class
Class II
Model Specifications
Sterile folding earhook type, sterile folding headband type, sterile boat-shaped earhook type, sterile ship-shaped headband type
无菌折叠形耳挂式、无菌折叠形头带式、无菌船形耳挂式、无菌船形头带式
Approval Department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration Information
Registration Number
豫械注准20182140825
Approval Date
October 18, 2022
Expiry Date
November 24, 2023
Registrant
Name
SHENGGUANG MEDICAL Instrument Co., Ltd.
圣光医用制品股份有限公司
Province/Region
Henan
河南
Address
East section of Longshan Avenue, Hao County
郏县龙山大道东段
Production Facility
Production Address
平顶山市郏县龙山大道东段
Structure and Composition
English

Medical protective masks consist of a mask body (including nose clip), mask belt, sponge strip (optional), hook or adjustment buckle (optional).

中文

医用防护口罩由口罩体(含鼻夹)、口罩带、海绵条(可选)、挂钩或调节扣(可选)组成。