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Medical disposable protective clothing - NMPA Registration 豫械注准20182140516

Access comprehensive regulatory information for Medical disposable protective clothing 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20182140516 and owned by Henan PROVINCE Jianqi MEDICAL Equipment Co., Ltd.. The device was approved on August 05, 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20182140516
Medical disposable protective clothing
医用一次性防护服
NMPA Registration Number: 豫械注准20182140516
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Intended Use
English

It is used to provide barrier and protection for the blood, body fluids, secretions, etc. of potentially infectious patients that clinical medical staff come into contact with during work.

中文

供临床医务人员在工作时接触到的具有潜在感染性的患者血液、体液、分泌物等提供阻隔、防护用。

Device Classification
Device Class
Class II
Model Specifications
Model: aseptic one-piece, non-sterile one-piece, aseptic one-piece, non-sterile one-piece; Specifications: 100, 110, 120, 130, 140, 150, 160, 165, 170, 175, 180, 185, 190, 195, 200.
型号:无菌连身式、非无菌连身式、无菌分身式、非无菌分身式;规格:100、110、120、130、140、150、160、165、170、175、180、185、190、195、200。
Approval Department
Henan Provincial Drug Administration
河南省药品监督管理局
Registration Information
Registration Number
豫械注准20182140516
Approval Date
August 05, 2022
Expiry Date
September 17, 2023
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

This product is made of specially finished nonwovens by processing and sewing.

中文

本产品采用特种整理的非织造布经加工缝制而成。