Declaration Of Conformity - DEHAS EASYMATE RESERVOIR PM2300CE Serie Mode D'emploi

DECLARATION OF CONFORMITY

Classification:
Classification
criteria:
We herewith declare that the above mentioned products meet the provisions of the
following EC Council Directives and Standards. All supporting documents are retained
under the premises of the manufacturer and the notified body.
Directives:
Applied
Standards:
Notified Body:
Address:
Certification Registration No's:
Devices already manufactured:
Validity of DOC:
Notified Body for Pressure
Equipment:
Certification Registration No's:
Manufacture Representative:
Position:
Date of Issue:
DEHAS Medizintechnik GmbH
Langenfelde 17
23611 Bad Schwartau
GERMANY
EasyMate Reservoir:
PM2335 (CE), PM2345 (CE) Series
IIb
Clause 3.2 Rule 11 of Annex IX of MDD
General Application Directives: (MDD) Medical Device Directive,
Council Directive 93/42/EEC Of 14 June 1993 Concerning Medical
Devices, Directive 2007/47/EC Of The European Parliament and of
the Council of 5 September 2007 and 99/36/EC Transportable
Pressure Equipment Directive 1999.
ISO 15223-1:2012
EN 1041
BS EN 1251-1
BS EN:1251-2
BS EN:1251-3
BS EN 1418
BS EN:1626
BS EN:1797-1
Medcert GmbH /
Pilatuspool 2, 20355 Hamburg; GERMANY
4153GB43411109
SN traceability via Device History records
From 02/2013 to Date of Expiry
DEKRA Automobil GmbH /
Handwerkstraße 15, 70565 Stuttgart
Z-O-024-09900
Quality Manager
Manager Quality System/ISO Representative
26/February/2013
0482
BS EN:12300
EN ISO 14971
ISO 15001
ISO 7000
BS EN 60601-1-2
BS EN 60601-1-6
BS EN ISO 15614-1
BS EN ISO 18777
0482
Date of Expiry: 11/2016
2266