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07.8
Déclaration de conformité CE
E C D e c l a r a t i o n o f C o n f o r m i t y
Manufacturer: custo med GmbH | Leibnizstrasse 7 | 85521 Ottobrunn, Germany
We hereby declare under our sole responsibility that the
CUSTO DIAGNOSTIC SYSTEM
is in conformity with the basic requirements according to Annex I of the Medical Device Directive
93/42/EEC. The conformity assessment procedure is based on Annex II (excluding section 4),
Medical Device Directive 93/42/EEC.
Notified body:
ID number:
Certificate registration no.:
Date of issue
Certificate expiry date
Product Category
Medical Software
ECG Systems
Holter ECG Systems
ABPM Systems
Cardiac Rehabilitation Systems
Telemedical Systems
Polysomnography Systems
Pulmonary Function Systems
Ergometry Systems
Ottobrunn, 04 June 2013
Peter Müller
Monitorage ambulatoire de la pression artérielle avec custo screen 300 et custo diagnostic | GEB 0157 – DK 1084 | Version 003 – 05.06.2013 | custo med GmbH
to which this declaration relates
Testing Institute of Medical Devices Graz (PMG)
Technische Universität Graz
Kopernikusgasse 24, A-8010 Graz, Austria
0636
EGII-130001-002-1
Graz, 2013-04-30
Graz, 2018-04-29
CUSTO DIAGNOSTIC SYSTEM
custo screen 100/200/300/400
V001 / DK-1315 / CEK-0197
Product Name
custo diagnostic
custo cardio 100/100 BT
custo cardio 110/110 BT
custo cardio 130
custo cardio 200/200 BT
custo flash 110/220
custo flash 500/501/510
custo cor 3/12
custo guard 1/3
custo care card
custo guard 1/3
custo kybe
custo guard 1/3
custo night 300/310
custo vit m R
custo spiro mobile
custo spiro protect
custo ec3000
custo er2100
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