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NanoZoomer product range and its possibility
Important Notice:
Following products are CE marked under EU’s In Vitro Diagnostics Directive (IVDD) for in vitro diagnostic use:
NanoZoomer S360, NanoZoomer S210, NanoZoomer S60, NanoZoomer-SQ including optional software e.g. NDP.view2 (U12388-21), NDP.view2 plus (U12388-22) and NDP.serve3 software (U13173-21, -22, -23).
In China, following products are registered for in vitro diagnostic use:
NanoZoomer S360, NanoZoomer S210, NanoZoomer S60 and NanoZoomer-SQ.
In Canada, NanoZoomer S360 (C13220-31) has Medical Device License (License No. 97957).
In Russia, following products are registered as medical device:
NanoZoomer S360, NanoZoomer S210, NanoZoomer S60 and NanoZoomer-SQ.
In Israel, following products are registered as medical device:
NanoZoomer S360, NanoZoomer S210, NanoZoomer S60 and NanoZoomer-SQ.
In the US, Japan and other countries, NanoZoomer is for research use only and is not permitted to use for clinical diagnostic purposes.