Covid 19 : Manatec Biomedical works to serve you with PhysioFlow advanced technologies,
designed to evaluate cardiac function
The new reference in Cardiac Output monitoring


Certificates


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 EC DECLARATION OF CONFORMITY - DIRECTIVE 2014/53/EU (RED) red_declaration_EN_FR
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 NF EN ISO 13485:2016 NF_EN_ISO13485_2016
Last update : September 2020 - Contact - Legal - Manatec Biomedical