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Certificate of Compliance: Certificate's Holder: Yiwu Fuyao Medical Instrument Co., LTD

This certificate confirms that Yiwu Fuyao Medical Instrument Co., Ltd. has received certification from Ente Certificazione Macchine Srl for its protective masks. The masks were verified to meet the requirements of European standard EN 149:2001+A1:2009. The certificate is valid until April 3, 2025. Ente Certificazione Macchine Srl has determined that the manufacturer's technical documentation demonstrates compliance with the requirements for use of the ECM certification mark for personal protective equipment according to EU Directive 2016/425.

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0% found this document useful (0 votes)
142 views1 page

Certificate of Compliance: Certificate's Holder: Yiwu Fuyao Medical Instrument Co., LTD

This certificate confirms that Yiwu Fuyao Medical Instrument Co., Ltd. has received certification from Ente Certificazione Macchine Srl for its protective masks. The masks were verified to meet the requirements of European standard EN 149:2001+A1:2009. The certificate is valid until April 3, 2025. Ente Certificazione Macchine Srl has determined that the manufacturer's technical documentation demonstrates compliance with the requirements for use of the ECM certification mark for personal protective equipment according to EU Directive 2016/425.

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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. 4Q200404M.YFM0N51

Certificate’s Yiwu Fuyao Medical Instrument Co.,


Holder: Ltd.
Third Floor Building B2 No. 23 Yongjin Road, Yiwu
City, Zhejiang Province, China

Certification ECM
Mark: European Type
Conformity Approved

Product: Protective Mask


Model(s): 17.5 x 9.5 cm, KN95
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: 04 April 2020
Expiry date: 03 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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