User Manual
DICOM Camera
V
EU DECLARATION OF CONFORMITY
For medical products according to regulation (EU) 2017/745
Manufacturer:
meso international GmbH
Markt 21 – 23
09648 Mittweida
Deutschland
Single Registration Number (SRN): (TBA)
Product Description:
Product group:
DICOM Camera
Basic-UDI-DI:
426033676-DC-Y4
Models:
DC-CPB – DICOM Camera Pro
DC-CC – DICOM Camera Compact
DC-CC2 – DICOM Camera Compact 2
Intended purpose:
Recording, temporary storage and transfer of
photographic medical images and video
GMDN:
58857 - Multi-purpose digital medical camera
Classification:
Class I device according to Annex VIII, rule 10 and rule 13 of MDR (EU) 2017/745
Statement:
meso international GmbH assumes sole responsibility for issuing this EU Declaration of
Conformity.
The conformity assessment was carried out in accordance with Annex IV of MDR (EU)
2017/745.
Applied Specifications:
EN ISO 13485:2016
Medical devices
—
Quality management systems
EN ISO 14971
Application of risk management to medical devices
EN 62304
Medical device software
—
Software life cycle processes
EN 60601-1
Medical Electrical Equipment
EN 60601-1-4
Programmable electrical medical systems
EN 60950-1:2006+A11:2009+A1:2010+A12:2011, EN 50332-2:3003, EN 300 328 V1.7.1, EN 300 440-1
V1.6.1, EN 300 440-2 V1.4.1, EN 301 893 V1.6.1, EN61000-3-2:2006+A1:2009+A2:2009, EN61000-3-
3:2008, EN 301 489-1 V1.9.2, EN 301 489-1 V2.2.1, EN 301 489-3 V1.6.1, EN 302 291-1 V1.1.1, EN 302 291-
2 V1.1.1, EN62311:2008, EN 55024:2010, EN 55022:2010/AC:2011
Mittweida, 2020-04-01
Place, Datum
Dipl.-Math. Christian Schwerin
Managing Director / Responsible person according to MDR, Art. 15
Summary of Contents for DC-CC
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