R-Biopharm RIDA qLine Scan, Руководство пользователя

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11 Corrective action/Notification to authorities
For users in the European Union: Serious incidents occurring in the context of the product
must be reported to R-Biopharm AG and the responsible national authority.
12 Conformity IEC 61326-2-6 and RoHS3
The CE marking of the RIDA qLine® Scan confirms that the RIDA qLine® Scan is compliant
with Regulation (EU) 2017/746 („In Vitro Diagnostic Medical Devices“).
In addition, the RIDA qLine® Scan fulfils the EMC protection requirements according
to EN 61326-2-6. The RIDA qLine® Scan is compliant with the current RoHS Directive.
13 Version Number
Version Number Chapter and Description
Version 1 (2018-11-27) Previous version
Version 2 (2022-04-08) IVDR Adaptation:
Labels
2.3.2 Requirements
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Disposal
11 Corrective action/Notification to authorities
13 Version Number