DEHAS Medizintechnik GmbH
Langenfelde 17
23611 Bad Schwartau
GERMANY
EasyMate Reservoir:
PM2335 (CE), PM2345 (CE) Series
Classification:
IIb
Classification
criteria:
Clause 3.2 Rule 11 of Annex IX of MDD
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:
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.
Applied
Standards:
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
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
Notified Body:
Medcert GmbH / 0482
Address:
Pilatuspool 2, 20355 Hamburg; GERMANY
Certification Registration No’s:
4153GB43411109
Date of Expiry: 11/2016
Devices already manufactured:
Validity of DOC:
SN traceability via Device History records
From 02/2013 to Date of Expiry
Notified Body for Pressure
Equipment:
DEKRA Automobil GmbH / 2266
Handwerkstraße 15, 70565 Stuttgart
Certification Registration No’s:
Z-O-024-09900
Manufacture Representative:
Quality Manager
Position:
Manager Quality System/ISO Representative
Date of Issue:
26/February/2013
DECLARATION OF CONFORMITY
0482
