Instructions for Use
Resting & Stress ECG with seca ct330/331 and seca diagnostic 5.9
5.4 EC Declaration of Conformity
Simplified declaration of conformity
seca ct330/331 complies with the requirements of the Medical Device
Regulation (EU) 2017/745 and Directive 2011/65/EU.
Hereby, custo med declares that the radio device type(s) custo
screen 300 (seca screen 300), custo guard holter (seca guard
holter) and custo cardio 300 BT (seca ct331) is/are in compliance
with Directive 2014/53/EU.
The full text of the EC declaration of conformity is available at the
following internet address:
https://www.customed.de/information/zertifizierung/konformitaetse
rklaerungen
Declarations of Conformity for accessories and supplementary parts, if
applicable, can also be found there.
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