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Shannon Electronics
Voorweg 200
2716 NK Zoetermeer
The Netherlands
www.shannonelectronics.nl
SRN: NL-MF-000001542
This declaration of conformity is issued under the sole responsibility of the manufacturer Shannon
Electronics. The device covered by the present declaration is in conformity with all regulations below,
including compliance with related Essential Requirements.
Product Name:
Intended use:
Basic UDI-DI:
Classificazione Nazionale
Dispositivi medici (CND):
Product Options:
The object of the declaration described above is in conformity with the following regulations:
EU Regulation:
Device Classification:
Conformity Assessment
Path:
Name/Address/ID of
Notified Body:
Standards and Common
Specifications:
EU declaration of conformity
SPA Dual Patch sensor
Dual Patch sensor for use with SPA Main Switch Unit
87202994975SPADualPatchL2
Y240918, control sensors
Pads for Dual Patch sensor
Regulation (EU) 2017/745 of the European Parliament and of the
Council of 5 April 2017 on medical devices (MDR)
Class I based on Annex VIII and Rule 1
Not Applicable – Class I device
Not Applicable – Class I device
The product listed above has been tested in a typical configuration as
described in the manufacturer's documentation and is in conformity
with the following Directives of the relevant Union harmonisation
legislation:
2014/30/EU
2011/65/EU
The product described above is in conformity with the following
relevant harmonised generic standards:
EN 61000-6-1:2007
EN 61000-6-3:2007
On the harmonisation of the laws of the
Member States relating to electromagnetic
compatibility (EMC)
On the restriction of the use of certain
hazardous substances in electrical and
electronic equipment (ROHS)
Electromagnetic compatibility (EMC) ---
Immunity for residential, commercial and light-
industrial environments
Electromagnetic compatibility (EMC) ---
Emission standard for residential, commercial
and light-industrial environments
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