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CE For Ultrasound Machine New

The document is a Verification of Compliance for ultrasound machines manufactured by Shanghai Ro-Chain Medical Co., Ltd., covering models RC-BW580, RC-BW500, and others. It confirms that a Technical Construction File exists and meets the essential requirements of the Medical Devices Directive 93/42/EEC. The certificate is valid from May 2020 to May 2025, with the manufacturer responsible for ensuring compliance before market placement.

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Rodrigo Espinoza Cors
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65 views1 page

CE For Ultrasound Machine New

The document is a Verification of Compliance for ultrasound machines manufactured by Shanghai Ro-Chain Medical Co., Ltd., covering models RC-BW580, RC-BW500, and others. It confirms that a Technical Construction File exists and meets the essential requirements of the Medical Devices Directive 93/42/EEC. The certificate is valid from May 2020 to May 2025, with the manufacturer responsible for ensuring compliance before market placement.

Uploaded by

Rodrigo Espinoza Cors
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 or read online on Scribd
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Verification of Compliance No, EC.1282.0A141283,WHH0484 Certificate’s Holder: Shanghai Ro-Chain Medical Co.,Ltd Building 1, kanggiao Road 787, Pudong New District, Shanghai, China Product: Ultrasound machine Model(s): RC-BW580, RC-BW500, RC-BW350, RC-BW370, RC-F3, RC-F5, RC-L3, RC-L5, RC-MU15, RC-P3, RC-P5, RC-P6, RC-P8, RC-T5, RC-T6, RC-T8, RC-T60 Directives: 93/42/EEC Medical devices Standards: EN 13060:2014 EN 61010-1:2010 EN 60601-1-2:2015 ENISO 14971:2012 i x BO Kl0 I S = ®o S) I ry cay Remark: This Verification of Compliance has been issued on a voluntary basis. ECM confirms that a Technical Construction File (TCF) is existent for the above listed product(s). The TCF satisfactorily covers the essential requirements of the above listed Directive(s) Other relevant Directives have to be observed in case they are applicable. This Document is only valid for the equipment and configuration described and in conjunction with the ‘TOF detailed above. Whereas the Manufacturer is responsible of the certification of the product(s) and ot exempted to perform all the necessary activities before placing the product(s) on the market. The Manufacturer is also responsible of the internal production control to ensure the product(s) are in compliance with the essential requirements of the above mentioned Directive(s). Date of issue MAY 2020 Expiry date MAY 2025 Certification Chief Manager Certificate - Ceptucbukat — ae Ente Certificazione Machine Sri Vie Mincio, 386/a ~ 41056 Savignano s./P. (MO) - ITALY ‘@ +39 059 763736 - +39 059 766306 4 +39 059 761838 [1 [email protected] &) www.entecerma.it

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