Sonomed SONOMED DOPPLER MD4, User Manual

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Declaration of Conformity EC
no 08/2017/EN
Sonomed Sp. z o. o.
02-118 Warszawa
Ul. Pruszkowska 4 d
Poland
Tel. (4822) 654 15 06
Fax. (4822) 654 15 07
As a Manufacturer of the
SONOMED Doppler Blood Flow Detector
MD4, MD4-CW8
Declares that According rule 10 MDD 93/42 and Rozporządzenie Ministra
Zdrowia dated 5 11 2010; DZ U 215 poz. 1416 is a medical device class IIa
Device has been designed and manufactured in a way to conform Medical Devices Directive 93/42/EEC and to the
following European Union harmonized standards

PN-EN 60601-1: 2011 / A1:2014-02

PN-EN 60601-1-2: 2007 / AC:2010

PN-EN 60601-1-6: 2010

PN-EN 60601-2-37: 2008

PN-EN ISO 14971: 2012

PN-EN 62366-1:2015

PN-EN 980: 2010

PN-EN 1041: 2010
The assesment was done with Notified Body 2460
signed
Warszawa, 30 08 2017
President
Paweł Karłowicz