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ABPM with custo screen 300 and custo diagnostic | GEB 0154 – DK 1055 | Version 002 – 05.06.2013 | custo med GmbH
07.8
EC Declaration of Conformity
V001 / DK-1315 / CEK-0197
EC Declaration of Conformity
Manufacturer: custo med GmbH | Leibnizstrasse 7 | 85521 Ottobrunn, Germany
We hereby declare under our sole responsibility that the
CUSTO DIAGNOSTIC SYSTEM
to which this declaration relates
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:
Testing Institute of Medical Devices Graz (PMG)
Technische Universität Graz
Kopernikusgasse
24,
A-8010
Graz,
Austria
ID number:
0636
Certificate registration no.:
EGII-130001-002-1
Date of issue
Graz, 2013-04-30
Certificate expiry date
Graz, 2018-04-29
CUSTO DIAGNOSTIC SYSTEM
Product Category
Product Name
Medical Software
custo diagnostic
ECG Systems
custo cardio 100/100 BT
custo cardio 110/110 BT
custo cardio 130
custo cardio 200/200 BT
Holter ECG Systems
custo flash 110/220
custo flash 500/501/510
custo cor 3/12
custo guard 1/3
ABPM Systems
custo screen 100/200/300/400
Cardiac Rehabilitation Systems
custo care card
custo guard 1/3
Telemedical Systems
custo kybe
custo guard 1/3
Polysomnography Systems
custo night 300/310
Pulmonary Function Systems
custo vit m R
custo spiro mobile
custo spiro protect
Ergometry Systems
custo ec3000
custo er2100
Ottobrunn, 04 June 2013
Peter Müller
Summary of Contents for custo screen 300
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