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Certificates

Please note!
EC Medical Device Certificates are valid for EU-versions of "Imedis Expert", "MiniExpert DT", "MiniExpert T" devices only, which have registered serial numbers (please refer to type label of device). EC Medical Device Certificates are not applicable in general for other versions of IMEDIS devices!
Certificate of conformity to the requirements of ISO 13485:2016 ¹22IMLO35 issued on 2022-11-30.
Medical devices — Quality management systems — Requirements for regulatory purposes.
Printer version: RU, EN.
Online verification: AQC.
Cerificate ¹EGIV-160988-096-08 issued on 2016-08-29 by The testing and Certification Institute of Medical Devices Graz, notified body no.0636, for the product "Imedis MiniExpert DT".
Printer version: certificate
Cerificate ¹EGIV-160978-062-12 issued on 2016-07-26 by The testing and Certification Institute of Medical Devices Graz, notified body no.0636, for the product "Imedis MiniExpert T".
Printer version: certificate
Cerificate ¹EGIV-150890-096-05 issued on 2015-03-31 by The testing and Certification Institute of Medical Devices Graz, notified body no.0636, for the product "Imedis MiniExpert DT".
Printer version: certificate
Cerificate ¹EGIV-120731-055-16 issued on 2012-01-31 by The testing and Certification Institute of Medical Devices Graz, notified body no.0636, for the product "Imedis Expert".
Printer version: certificate
Cerificate ¹EGIV-090626-096-01 issued on 2009-12-09 by The testing and Certification Institute of Medical Devices Graz, notified body no.0636, for the product "Imedis MiniExpert-DT".
Printer version: certificate
Cerificate ¹EGIV-050479-062-01 issued on 2005-10-24 by The testing and Certification Institute of Medical Devices Graz, notified body no.0636, for the product "Imedis MiniExpert T".
Printer version: certificate
Cerificate ¹EGIV-050463-055-07 issued on 2005-03-31 by The testing and Certification Institute of Medical Devices Graz, notified body no.0636, for the product "Imedis Expert".
Printer version: certificate
EC declaration of conformity ¹E01/10-0093 issued on 2001-10-11 for the product "Imedis-BRT".
Printer version: certificate


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