The new reference in Cardiac Output monitoring


Certificate scope / CountryDescriptionDownload URL
China Enduro registartion certificate in China SFDA_ENDURO
Europe EC certificate EC_certificate
Europe EC declaration of conformity (Enduro, Q-Link) EC_declaration_EN
Europe Déclaration CE de conformité (Enduro, Q-Link) EC_declaration_FR
Europe Déclaration CE de conformité (Electrodes PF-50) EC_declaration_PF50_FR
Europe EC declaration of conformity (PF-50 electrodes) EC_declaration_PF50_EN
Japan Q-Link registartion certificate in Japan QLINK_CERTIFICATE_JAPAN
Taïwan Cover letter Täwan coverLetterTaiwan
Taïwan Registartion certificate for Enduro and Q-Link in Taïwan TFDA_ENDURO_QLINK
USA Q-Link 510K certificate 510K_QLINK_K140102
USA Enduro 510K certificate 510K_ENDURO_K103283
USA Lab1 510k certificates 510K_LAB1_K060387
Worldwide ISO 13485_2003 ISO13485_2003
Worldwide ISO9001:2008, NF EN ISO 13485:2012 ISO9001_2008_IS013485_2012
Last update : February 2016 - Contact - Legal - Manatec Biomedical