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EUDAMED last updated this device on May 18, 2026
859420806ED70656EED7065 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by EXBIO Praha, a.s.. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08594208060079859420806ED70656EED7065(01)08594208060079
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0103080699REAGENTS FOR FLOW CYTOMETRY - OTHER14 warnings recorded — scroll inside the panel to see all entries.
CW010CW082CW083CW085CW087CW090CW093CW094CW119CW137CW158CW167CW313CW148No certificate specifically references this device's Basic UDI-DI.
Primary placement in Czechia; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | Jan 1, 2014 | Still on market |
| Austria | Jul 10, 2024 | Still on market |
| Germany | Jul 3, 2024 | Still on market |
| Denmark | Dec 12, 2022 | Still on market |
| EL | Apr 14, 2014 | Still on market |
| Hungary | Jun 22, 2015 | Still on market |
| Netherlands | Nov 12, 2025 | Still on market |
| Slovakia | Jan 8, 2014 | Still on market |
CZ-MF-000033468No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.