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EUDAMED last updated this device on Apr 7, 2026
85850389DB103KPDB 103-RTU-15 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by DB Biotech, a.s.. Placed on the EU market in Slovakia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0858503890255485850389DB103KPDB 103-RTU-15(01)08585038902554
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.
W01030705FIXING REAGENTS (HISTOLOGY/CYTOLOGY)No certificate specifically references this device's Basic UDI-DI.
Primary placement in Slovakia; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SlovakiaPrimary placement | Still on market |
SK-MF-000051838No 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.