The 3 Reasons
Our Statement for COVID-19See the statement
In the USA, C13220-01MD NanoZoomer S360MD Slide scanner system is intended for in vitro diagnostic use.
In EU, C13220-21MDEU and C16600-21MDEU are 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 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.
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