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15 Declaration of Conformity
Classification:
Class IIa (MDD Annex IX, Rule 15)
Manufacturer:
SciCan Ltd.
Manufacturer Address:
1440 Don Mills Road
Toronto, Ontario M3B 3P9 / Canada
Fax
+1 416-445-2727
Telephone
+1 416-445-1600
European Representative:
SciCan GmbH
Wangener Straße 78
88299 Leutkirch
Germany
We herewith declare that the above mentioned products meet the provisions of the following EC Council
Directive and Standards and that SciCan Ltd. has exclusive responsibility for the content of this Declaration
of Conformity. All supporting documentation is retained at the manufacturer’s premises.
DIRECTIVE
General Applicable Directive:
Medical Device Directive: Council Directive 93/42/EEC of 14 June 1993 concerning medical devices [(MDD
93/42/EEC, Annex II, excluding (4)].
Standards:
Harmonized Standards (published in the Official Journal of the European Communities) applicable to this
product are:
EN ISO 13485, EN 61010-1, EN 61010-2-040, EN ISO 14971, EN 62304, 62366-1, EN 13060.
Additional Product Specific Standards applicable to this product are:
EN 61326-1
Notified Body:
TÜV SÜD Product Service GmbH
Ridlerstraß 65,
D-80339 München, Deutschland
Identification No. 0123
Date CE Mark was affixed:
April 12, 2021
