30 Declaration of Conformity
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Declaration of Conformity
The manufacturer of the products according to this declaration is:
Dr. Jean Bausch GmbH & Co. KG
Oskar-Schindler-Straße 4
50769 Cologne
Germany
Directives and standards to which the conformity is declared:
Directive 93/42/EEC (MDD)
Directive 2007/47/EC
Directive 2014/53/EU
EN 60601-1:2006 + A1:2013
EN 60601-1-2:2007
EN 60601-1-6:2010 + A1:2015
EN 62304:2006 + A1:2015
Products for which this conformity is declared:
Bausch OccluSense Set BK 5000
Bausch OccluSense Handheld BK 5001
Bausch OccluSense Sensors BK 5025
Bausch OccluSense Sensors BK 5035
Product classification:
Class I according to directive 93/42/EC including directive 2007/47/EC annex IX, rule 5 & rule 12
Conformity assessment procedure according to:
Annex VII of the directive 93/42/ECC (MDD)
Dr. Jean Bausch GmbH & Co. KG hereby declares that the products mentioned above, meet the require-
ments of the Directive 93/42/ECC (MDD) and the Directive 2007/47/EC for medical devices as well as the
Directive 2014/53/EU for radio equipment.
The technical documentation which meets the requirements for verification of compliance of the above men-
tioned directives and standards is documented in part A and B of the technical file and is available for the
regulatory authorities for medical devices.
Validity of this declaration:
This declaration is valid from 2018-06-01 to 2020-05-25.
_____________________________________
Signed by: André Bausch
Position: General Manager of Dr. Jean Bausch GmbH & Co. KG
Date of signature: 2018-06-01
Place of signature: Cologne - Germany
Dr. Jean Bausch GmbH & Co. KG
Oskar-Schindler-Str. 4
D-50769 Köln - Germany
Tel: +49 (221) - 70 93 6-0
Fax: +49 (221) - 70 93 6-66
www.bausch.net
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