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EUDAMED last updated this device on Jul 28, 2025
594054038AGARmENTEROCO1VZ34003255 is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by DELTAROM SRL. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05940540380079594054038AGARmENTEROCO1VZ34003255(01)05940540380079
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.
W0104010306CULTURE MEDIA IN BOTTLESNo certificate specifically references this device's Basic UDI-DI.
Primary placement in Romania; available across 1 country total.
Placed on the market in Romania; per-country availability dates not published.
RO-MF-000035924No 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.