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In EU, C13220-21MDEU is CE marked under EU‘s In Vitro Diagnostic Medical Device Regulation(IVDR) for in vitro diagnostic use.
In China, following products are registered for in vitro diagnostic use:
C13220-01 NanoZoomer S360, C13239-01 NanoZoomer S210, C13210-01 NanoZoomer S60 and C13140-01 NanoZoomer-SQ.
In Canada, C13220-31 NanoZoomer S360 has Medical Device License (License No. 97957).
In Taiwan,C13220-01 NanoZoomer S360 is registered as medical device.
In the US, Japan and other countries, NanoZoomer series are for research use only and not permitted to use for clinical diagnostic purposes.
C13220-01 NanoZoomer S360 Digital slide scanner is not sold as the IVDD unit to EU region after May 27th in 2022.
Since "In Vitro Diagnostic Medical Device Directive(IVDD)" for CE mark is going to switch "In Vitro Diagnostic Medical Device Regulation(IVDR)", sales for the NanoZoomer series for IVDD has been finished.
The replacement is "C13220-21MDEU NanoZoomer S360MD Slide scanner system" complying the IVDR.
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