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EUDAMED last updated this device on May 25, 2026
69383846XQ064Y2Lyse for Hematology Analyzers Use is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Labnovation Technologies, Inc.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0693838461275269383846XQ064Y299-30-001(01)06938384612752
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.
W01019001BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)1 warning recorded — scroll inside the panel to see all entries.
CW011No certificate specifically references this device's Basic UDI-DI.
Primary placement in Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Still on market |
CN-MF-000015953No 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.69383846TY006XYOn the marketAutomated HbA1c Analyzer69383846TY006XYOn the marketCandida Albicans/Trichomonas vaginalis Antigen Rapid Test Kit (Immunochromatography)B-06938384622058On the marketChromatography ColumnB-06938384641202On the marketChromatography ColumnB-06938384641103On the market