The 3 Reasons
Our Statement for COVID-19Remote Diagnoses and Digital Pathology
In the USA, C13220-01MD NanoZoomer S360MD Slide scanner system is intended for in vitro diagnostic use.
In Europe, following products are regulatory compliant for IVDR (EU), UKCA (UK) and IvDO (CH) for in vitro diagnostic use:
C13220-21MDEU NanoZoomer S360MD Slide scanner system, C16600-21MDEU NanoZoomer S60v2MD Slide scanner system and C16300-21MDEU NanoZoomer S20MD Slide scanner system.
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.
In Taiwan, C13220-01 NanoZoomer S360 is registered as medical device.
In Korea, C13220-61MDK NanoZoomer S360MD Slide scanner system is registered as in vitro diagnostic medical device.
In Japan, C13220-11MDJ Slide scanner system is approved as medical device.
For other countries, NanoZoomer series are for research use only and not permitted to use for clinical diagnostic purpose.
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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