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CE_Laser Therapy Systems

CE_Laser Therapy Systems

Product catalog summary
Certificate of Compliance Overview
This document is a Certificate of Compliance issued by Ente Certificazione Macchine Srl for Beijing LaserTell Medical Co., Ltd. It certifies that the company's Laser Therapy Systems, including models such as DepiMED Plus, DepiMED, VenaMED, FemiMED, NdMED, ClearMED, AlexMED, MaxMED, and iShape, comply with specific European standards and directives.
Product Verification and Standards
The products have been verified against several standards, including EN 60335-1:2012, EN55014-1:2006+A2:2011, EN 55014-2:1997+A2:2008, EN 61000-3-2:2006+A2:2009, EN 61000-3-3:2013, and IEC 60825-1:2007+A1:2008. These standards relate to the CE Directives 2014/35/EU for Low Voltage and 2014/30/EU for Electromagnetic Compatibility.
Certification Details
The certificate confirms that the products meet the requirements for the ECM Certification Mark. The compliance mark can be affixed to the products according to ECM regulations, which are available on their website. The certificate's validity can also be checked online.
Additional Remarks
The certification was conducted on a voluntary basis and does not imply an assessment of the production process. A Technical Construction File (TCF) for the marking process is in place, and the manufacturer is responsible for initiating the marking certification procedure before applying the mark to the products.
Validity
The certificate was issued on 31 March 2016 and expired on 30 March 2021.
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Catalog excerpts

CE_Laser Therapy Systems-1

Certificate – Cертификат – 證明書 – Certificat – 증명서 – ‫شهادة‬ Certificate’s Holder: Certification ECM Mark: Beijing LaserTell Medical Co., Ltd. Block1, No.12 Jingsheng South 2nd Rd., JQ Science Park, Tongzhou District, Beijing, China European Conformity Type Approved Product: Model(s): Laser Therapy Systems DepiMED Plus; DepiMED; VenaMED; FemiMED; NdMED; ClearMED; AlexMED; MaxMED; iShape Standard: EN 60335-1:2012, EN55014-1:2006+A2:2011, EN 55014-2:1997+A2:2008, EN 61000-3-2:2006+A2:2009, EN 61000-3-3:2013, IEC 60825-1:2007+A1:2008 related to CE Directive(s): 2014/35/EU (Low Voltage) 2014/30/EU (Electromagnetic Compatibility) Remark: The product(s) has been verified on a voluntary basis. The product(s) satisfies the requirements of the Certification Mark of ECM, in reference to the above listed Standard(s). The above Compliance Mark can be affixed on the product(s) accordingly to the ECM regulation about its release and its use. The regulation can be found at www.entecerma.it. This Certificate of Compliance can be checked for validity at www.entecerma.it This verification doesn’t imply assessment of the production of the product(s). Additional information, clarification about the Marking: We attest that a TCF for the Marking process is in place. Whereas the Manufacturer is Responsible to start the Marking Certification Procedure and to perform all the necessary activities, as required by the Directive before placing the Mark on the product(s). Date of issue 31 March 2016 Expiry date 30 March 2021 Chief Manager Tim Mahan Deputy Manager Viola Miller Ente Certificazione Macchine Srl Via Ca’ Bella, 243 – Loc. Castello di Serravalle – 40053 Valsamoggia (BO) - ITALY  +39 051 6705141  +39

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