豫械注准20202141378

Medical surgical masks

医用外科口罩
SHENGGUANG MEDICAL Instrument Co., Ltd.·Class II·NMPA·Approved October 18, 2022
Device classification
Device class
Class II
Model specifications
Rectangular, boat-shaped
长方形、船形
Approval department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration information
Registration number
豫械注准20202141378
Approval date
October 18, 2022
Expiry date
December 07, 2025
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
Intended use
English

It is worn by clinical medical staff during invasive procedures, covering the user's mouth, nose and jaw, providing a physical barrier to prevent the direct penetration of pathogenic microorganisms, body fluids and particles.

中文

供临床医务人员在有创操作过程中佩带,覆盖住使用者的口、鼻及下颌,为防止病原体微生物、体液、颗粒物的直接透过提供物理屏障。

Structure and composition
English

Made of non-woven fabric or non-woven composite, the nose clip is made of plastic material.

中文

由无纺布或无纺布复合材料制成,鼻夹由可塑性材料制成。

About this record

Access comprehensive regulatory information for Medical surgical 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20202141378 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.