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para su producto. Póngase en contacto con ARCHOS en cualquier momento.
Fabricado por: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Empresa: GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Dirección: Zone A, 5/F., Investment Building, No. 12, Huizhan East Rd., Torch
Development District, Zhongshan, Guangdong, 528437, China
Representante europeo autorizado:
Empresa: MDSS - Medical Device Safety Service GmbH
Dirección: Schigraben 41, 30175 Hannover, Alemania
Conformidad con la normativa europea
Gestión de riesgos EN/ISO 14971:2007
Etiquetado EN 15223:2012
Manual de usuario EN 1041:2008
Requisitos generales
de seguridad
EN 60601-1:2006/AC2010
EN 60601-1-11:2010
Esgmomanómetros
no invasivos
Requisitos
generales
EN 1060-1:1995+A2:2009
EN 1060-3:1997+A2:2009
EN 1060-4:2004
Compatibilidad
electromagnética
EN 60601-1-2:2007/AC:2010
Ciclo de vida del software EN 62304:2006/AC:2008
Usabilidad EN 60601-1-6:2010
Manuel_BPM_book.indd 106 06/06/2014 10:21:27
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