Device overview
3.2
European registration
Device conformity
Single Registration Number
Basic-UDI-DI
3.3
Important labels on the packaging
TOP
This is the correct upright position of the shipping container for transport and/or storage.
FRAGILE GOODS
The contents of the shipping container are fragile, so it must be handled with care.
PROTECT FROM MOISTURE
The shipping container must not be exposed to rain and kept in a dry environment.
TEMPERATURE LIMITATION
The shipping container must be stored, transported and handled within the indicated temperature
range (-20 °C to +60 °C).
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23 any Device designation
24 Manufacturer's logo
Device conformity according to EU directives.
Notified body:
mdc medical device certification GmbH – Notified Body CE 0483
Tel: +49 (0)711 253597 0
Fax: +49 (0)711 258597 10
E-mail: mdc@mdc-ce.de
Website: www.mdc-ce.de
Address: Kriegerstrasse 6, D-70191 Stuttgart, Germany
SRN: DE-MF-000010680
Basic-UDI-DI
040506740100039N
Rev.: 24 / 01.2024
Device assignment
ROTANTA 460 / 460R / 460RC / 460RF
(medical device)
AB5650en