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EU DoC - Selectra ProM Rev. 19

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52 views3 pages

EU DoC - Selectra ProM Rev. 19

Uploaded by

ahmed.abdelaziz221b
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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EU Declaration of Conformity .

ELI IechGroup
C E
EMPOWER NG IVD

ELlTechGroup B.V.
Van Rensselaerweg 4
6956 AV Span keren
The Netherlands

declares under sole responsibility that the IVD medical devices specified below (including the listed accessories)
and to which this declaration relates, conform to the provisions of:
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro
diagnostic medical devices and repealing Directive 98179/EC and Commission Decision 2010/227/EU
(1 VDR”)
• Directive 201 11651EU of the European Parliament and of the Council of 8 June 2011 on the restriction
of the use of certain hazardous substances in electrical and electronic equipment, including Commission
Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of
the European Parliament and of the Council as regards the list of restricted substances (RoHS”).

These IVD medical devices carry the CE-marking and are notified in accordance with the IVDR.
Catalogue number Description GTIN
6003-404 Selectra ProMTM [0/ISE/PSID] 3661540 60478 2
6003-405 Selectra ProMTM [O/PSID] 3661540 60479 9
6003-406 Selectra ProMTM [O/ISE] 3661540 60480 5
6003-407 Selectra ProMTM [0] 3661540 60481 2
6003-435 Selectra ProMTM [CIISEIPSID/US] 3661540 60039 5
6003-439 Selectra ProM [IJTE] 3661540 60482 9
6003-439P Selectra ProMTM [LITE/PSID] 3661540 60483 6

Product Chemistry analyzers


EMDN code W02010101
GMDN code 56676
Intended purpose Automated clinical chemistry analyzer, to be used in combination with specific
reagents, for in vitro diagnostic measurement of analytes in samples of serum,
plasma, urine, and agueous standard solutions.
Risk Class A
Accessories See Annex 1
SRN of manufacturer NL-MF-000021018
Basic UDI-DI 3661540Pro-series8A

Spankeren, December 2022

Person sible for Regulatory Compliance (PRRC)

EU DoC - Selectra ProM rev. 19 Page 1 of 3


EU Declaration of Conformity •fELITechGroup
C E EMPOWERING VD

List of applied (harmonized) standards

Standard version Description Tested 1


certified by
Safety requirements for electrical equipment for
IEC 61010-1:2010 measurement, control, and laboratory use -

Part 1: General requirements


Safety requirements for electrical equipment for
measurement, control, and laboratory use -

IEC 61010-2-010:2014
Part 2-010: Particular requirements for laboratory
equipment for the heating of material

Safety Safety requirements for electrical equipment for


DEKRA
measurement, control, and laboratory use -

IEC 61010-2-081:2015 Part 2-081: Particular requirements for automatic


and semi-automatic laboratory equipment for
analysis and other purposes
Safety requirements for electrical equipment for
measurement, control, and laboratory use —

IEC 61010-2-101:2015
Part 2-101: Particular requirements for in vitro
diagnostic (IVD) medical equipment
Electrical equipment for measurement, control, and
IEC 61326-1:2006 laboratory use EMC requirements
- —

Part 1: General requirements


EMC Electrical equipment for measurement, control and DEKRA
laboratory use EMC requirements
— —

IEC 61326-2-6:2006
Part 2-6: Particular requirements In Vitro
—

diagnostic_(IVD)_medical_equipment

Quality Medical devices—Quality management


ISO 13485:2016 LRQA
systems systems—Requirements for regulatory purposes.

SU DoC Selectra ProM rev. 19


-
Page 2 of 3
CE EU Declaration of Conformity •ELITechGroup
EMPOWERING VD

Annex 1 — List of IVD accessories

Catalogue number Description EMDN GMDN GTIN


3201-019 Precision Test Solution W0201010185 58048 3661540 60042 5
6002-706 CuvetteRotorSet W0201010180 61033 3661540600579

EU DoC Selectra ProM rev. 19


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Page 3 of 3

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