Declaration Of Conformity; Scican Gmbh - SciCan STATIM 5000S Operator's Manual

12. DECLARATION OF CONFORMITY

Certificate # Product
99-1010
STATIM 2000S Cassette Autoclave
99-1011 STATIM 5000S Cassette Autoclave
Classification:
Manufacturer:
Manufacturer Address:
European Representative:
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:
ISO 13485, EN 61010-1, EN 61010-2-040, EN ISO 14971, EN 62304, EN 13060:2014.
Additional Product Specific Standards applicable to this product are:
EN 61326-1
Notified Body:
Certificate:
Date CE Mark was affixed:
Class IIa (MDD Annex IX, Rule 15)
SciCan Ltd.
1440 Don Mills Road
Toronto, Ontario
M3B 3P9
Canada

SciCan GmbH

Wangener Straße 78
88299 Leutkirch
Germany
TÜV SÜD Product Service GmbH
Ridlerstraß 65,
D-80339 München, Deutschland
Identification No. 0123
G1 17 08 12160 057
March 24, 1998
Telephone (416) 445-1600
Fax (416) 445-2727
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