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Certificate of Compliance: Certificate's Holder: Zhangjiagang Xiehe Medical Apparatus and Instruments Co.,Ltd

This certificate provides details of compliance certification for protective masks from Zhangjiagang Xiehe Medical Apparatus and Instruments Co., Ltd. Specifically: - It certifies that the company's KN95 protective mask models XHM-02 comply with the European standard EN 149:2001+A1:2009 for personal protective equipment. - The certificate is valid from April 2, 2020 to April 1, 2025. - It allows the company to affix the ECM certification mark to their masks, indicating compliance with relevant CE directives for personal protective equipment.

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Roberto Manrique
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126 views1 page

Certificate of Compliance: Certificate's Holder: Zhangjiagang Xiehe Medical Apparatus and Instruments Co.,Ltd

This certificate provides details of compliance certification for protective masks from Zhangjiagang Xiehe Medical Apparatus and Instruments Co., Ltd. Specifically: - It certifies that the company's KN95 protective mask models XHM-02 comply with the European standard EN 149:2001+A1:2009 for personal protective equipment. - The certificate is valid from April 2, 2020 to April 1, 2025. - It allows the company to affix the ECM certification mark to their masks, indicating compliance with relevant CE directives for personal protective equipment.

Uploaded by

Roberto Manrique
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Certificate – Cертификат – 證明書 – Certificat – 증명서 – ‫شهادة‬ Form QAT_10-M04, version 00, effective since March 6th, 2020

Certificate of Compliance
No. 0P200402R.ZXM0T55

Technical Construction File no. TPJS20040123764

Certificate’s ZHANGJIAGANG XIEHE MEDICAL


Holder: APPARATUS AND INSTRUMENTS CO.,LTD
No.7th,Middle Xinzha Road,Zhashang Industrial
Zone,Yangshe Town,Zhangjiagang City,
Jiangsu 215600,China

Certification ECM
Mark: European Type
Conformity Approved

Product: PROTECTIVE MASK KN95

Model(s): XHM-02

Verification to: Standard:


EN 149:2001+A1:2009

related to CE Directive(s):
R 2016/425 (Personal Protective Equipment)
Remark: This document has been issued on a voluntary basis and upon request of the manufacturer. It is
our opinion that the technical documentation received from the manufacturer is satisfactory for the
requirements of the ECM Certification Mark. The conformity mark above can be affixed on the products
accordingly to the ECM regulation about its release and its use.
Additional information and clarification about the Marking:
The manufacturer is responsible for the CE Marking process, and if necessary, must
refer to a Notified Body. This document has been issued on the basis of the regulation
on ECM Voluntary Mark for the certification of products. RG01_ECM rev.3 available
at: www.entecerma.it
Issuance date: 02 April 2020
Expiry date: 01 April 2025
Reviewer Approver
Technical expert ECM Service Director
Amanda Payne Luca Bedonni

Ente Certificazione Macchine Srl


Via Ca’ Bella, 243 – Loc. Castello di Serravalle – 40053 Valsamoggia (BO) - ITALY
 +39 051 6705141  +39 051 6705156  info@entecerma.it  www.entecerma.it

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